Clinical Research Manager Resume Samples

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J Schaefer

Jennie

Schaefer

408 Kiel Summit

Philadelphia

+1 (555) 796 3447

408 Kiel Summit

Philadelphia

Phone

p +1 (555) 796 3447

Experience Experience

Dallas, TX

Asst Clinical Research Manager

Dallas, TX

Crona-Eichmann

Dallas, TX

Asst Clinical Research Manager

Identifies operational, logistical, and regulatory challenges related to the conduct of clinical trials and acts as a leader in overseeing their resolution
Collaborates with the DFCI QACT to develop study forms, database information, and to establish guidelines for monitoring data quality control
Assists the principal investigator in developing the protocol budget, in collaboration with Research Administration and the Grants and Contracts offices. Work with grant managers and other financial managers in the reporting and accounting of these funds
Responsible for the recruitment and oversight of coordinator staff as well as ensures that staff has completed mandatory training in a timely manner. Develops and oversees a program specific on-boarding and orientation process and participates in annual performance evaluations and competency assessments of research staff
Provides in-service training and serves as a resource to other clinical personnel including physicians, nurses, pharmacists and other allied health professionals regarding clinical trials, protocols, GCP guidelines, federal regulations and site SOPs
Assists the principal investigator in preparing manuscripts for publication
Oversees registration of protocol patients with QACT, study group registrar and pharmaceutical company as outlined in protocol

New York, NY

Clinical Research Manager

New York, NY

Watsica Group

New York, NY

Clinical Research Manager

Conducts site assessments visits to ensure research sites are implementing the study per protocol and to provide guidance for operational management
Develops and maintains a network of clinical and scientific contacts
Develop and lead the personal and professional development programs of clinical team personnel
Develop or contribute to protocol development as necessary
Conduct quarterly performance reviews and continuous employee development
Provide a leadership role in developing, implementing and evaluating the conduct of studies
Proactively engages senior clinical management in program risk discussions and provides well thought out solutions to issues

present

Dallas, TX

Oncology Clinical Research Manager

Dallas, TX

McLaughlin, Douglas and Price

present

Dallas, TX

Oncology Clinical Research Manager

present

Working with regulatory issues and the broader organization
Performance or compliance issues
The CRM is responsible for quality and compliance for assigned protocols in the country and oversees CRAs and/ or CTCs and training compliance
The CRM is responsible for clinical trial education to sites, and acts as the country POC for programmatically outsourced trials for assigned protocols
Examples of common problems include
The CRM is responsible for collaboration and relationship management with investigators for insourced and outsourced studies, with functional outsourcing vendors and other external partners
The CRM oversees country and site validations, site selection and recruitment in assigned protocols

Education Education

Bachelor’s Degree in Related Field

University of Southern California

Bachelor’s Degree in Related Field

Skills Skills

2+ years of Clinical Research experience
Experience with Word, submission activities and Annual Reports
Great interpersonal skills
Excellent communication skills (written and verbal)
Strong attention to detail
Highly organized
Able to multitask efficiently and effectively
Experience with Documentum and eCTD software
Position Title:Clinical Research Manager
Sector :Janssen

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15 Clinical Research Manager resume templates

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Clinical Research Manager Resume Examples & Samples

2+ years of Clinical Research experience
Bachelor's Degree in a related field
Experience with Word, submission activities and Annual Reports
Able to multitask efficiently and effectively
Experience with Documentum and eCTD software

Clinical Research Manager Resume Examples & Samples

A minimum of 5 or more years clinical monitoring and clinical operations experience within a pharmaceutical, biotechnology, or contract research organization is required
Experience of early clinical development, particularly with antiviral or anti-infectious disease compounds is preferred
Significant experience of Service Provider selection and management is required
In depth knowledge of the Code of Federal Regulations related to clinical research, ICH GCP guideline and other applicable regulations and practices is required
Ability to prioritize and handle multiple tasks and to facilitate and resolve cross-functional activities and issues required.Clinical Trial Administration

Clinical Research Manager Resume Examples & Samples

A Bachelor’s degree with a minimum of 10 years clinical research experience (this can be a combination of industry/academic related experience). OR a PhD or equivalent degree in Biological Science or related discipline with a minimum of 8 years related scientific / technical experience, including leadership / management role within Clinical Research
A minimum of 1-2 years of people management related experience is required for this role
Experience in the Code of Federal Regulations (CFR) for conducting clinical research trials is required
Orthopaedic (Spine) device experience is preferred
Investigational Device Exemption (IDE) experience is strongly preferred
Ability to provide strategic and scientific clinical research input across projects, including complex and / or transformational projects with a proven track record in delivering clinical programs within clinical / surgical research setting, on time, within budget and in compliance to SOPs and regulations is required
Comprehensive understanding of clinical trial regulations across multiple regions is preferred
Ability to lead teams to deliver critical milestones, including complex projects is required
Ability to collaborate across different functional areas within Clinical Research to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc.) to meet business objectives is required
Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders is required
This role will be located in Raynham, MA and will require up to 30% domestic and international travel
Connect - foster strategic partnerships with key internal & external stakeholders to ensure development and timely delivery of innovative EGS / EDS
Shape – build strong relationships with external stakeholders to shape and influence relevant policies
Lead – develop talent to provide strategic and scientific clinical research capability, including responsibility for professional development of direct reports
Deliver – ensure clinical programs are delivered on time, within budget and in compliance to regulations and SOPsClinical Research non-MD

Clinical Research Manager Resume Examples & Samples

Position Title:Clinical Research Manager
Sector :Janssen
Location: Taipei, Taiwan
Evaluates and projects resource needs for assigned portfolio, and liaises with local TCSM management for resource requests as appropriate
Strong interaction with Flex Resource managers to provide feedback on Flex Resource performance. Works with Flex Resource managers to on-board and off-board staff
Interviews, hires, develops and trains staff
For employees: Responsible for performance and development in accordance with the Performance Management guidelines, including talent development, coaching, mentoring and providing ongoing performance assessment
Ensures staff have a clear understanding and knowledge of GCO SOPs, Work Instructions and Company Policies supported by documentation of training compliance in Learning @ Pharma R&D
Ensures adequate, timely and compliant management of clinical studies through all phases of the trial- feasibility through database lock
Ensures studies are in a constant state of inspection-readiness. Works with Quality Management (QM) liaisons to ensure quality oversight of studies utilizing the available tools
Supports staff in communications with Ethics Committees, Health Authorities, Investigational Sites and groups external to GCO
Coaches staff in their role in local Health Authority site inspections and follow-up activities including CAPA generation
Communicates with staff on program changes, policy changes and priority shifts
Conducts Accompanied Site Visits with Site Managers
Review and approve expenses; assure expenses are in compliance with the company’s policies
Demonstrate Leadership Behaviors in alignment with Leadership Imperatives
Overall accountability for planning, executing and monitoring of clinical trials through all phases of the trial feasibility through database lock, and inspection-readiness for assigned Therapeutic Area or study portfolio in country or for TCSM activities of specific role (s)
Appropriate and timely issue escalation to line management and study team as appropriate. Report (suspicion) of fraud or scientific/ethical misconduct
Strong interaction with the R&D/Local Operating Company staff and departments within GCO and outside of GCO, i.e., (Regional Therapeutic Area Experts (RTAE), GCO Early Dev. & Clinical Pharmacology as applicable,, GCO Medical Affairs regional leadership, Central Trial Coordination (CTC), Integrated Data Services (IDS), Clinical Supplies Unit (CSU), Quality and Compliance (QC) and external vendor groups, Medical Affairs)
Participates in special initiatives as needed and guides rollout of new processes and procedures
Collaborates with the RTAE on country capabilities and study placement for assigned Therapeutic Area(s) or study portfolio
Accountable for study feasibility in country for assigned Therapeutic area or study portfolio
Supports metrics review and necessary follow-up actions
In some instances (i.e., smaller countries) backup to country leadership

Clinical Research Manager Resume Examples & Samples

Advanced degree preferred
Bachelor's degree in related field and five years of experience in clinical research, or an equivalent combination of education and relevant experience
Excellent interpersonal skills
Knowledge of medical terminology
Experience with a diverse range of research designs and methodologies are required to successfully reach goals, along with ability to lead educational efforts and hands-on training
Demonstrated ability to track project needs and deadlines to ensure tasks are completed in a timely manner to facilitate project success

Clinical Research Manager Resume Examples & Samples

Ensuring the committee structure is implemented as described in the study protocols and participation on committee
Assisting with committee and project report preparation to PCORI, our stakeholders, and to our DSMB among other groups
5 years of relevant experience
Bachelor’s degree in health related field
10 years of experience in clinical research including research management

Assistant Clinical Research Manager Resume Examples & Samples

Experience in protocol development, data compilation and analysis
Knowledge of cancer as a disease process, cancer treatment modalities, and the clinical trial process
Expert knowledge of Federal and State regulations as they relate to research
Strong interpersonal, organizational and communication skills

Clinical Research Manager Resume Examples & Samples

Hire, train, supervise and manage the performance of a team of CRAs; evaluate resource needs for ongoing and planned clinical trials within the assigned team and manage the trials with available resources; develop staff to improve the individual performance and that of the team; assure that the required level of knowledge and skills are present and trial sites are managed as per SOPs by the team
Interact with local medical, commercial and other key stakeholders to allocate trials which best support local as well as global business interests
Lead local team meetings, attend business meetings and global team meetings, or as GMO representation to other meetings as assigned
Supervise trial execution as related to monitoring and operational aspects and overall trial performance (e.g. meet project deliverables, quality targets, timelines, recruitment, etc) in the team; recognize potential challenges, identify and resolve issues, plan on appropriate actions including manage and direct associates with problem solving at site level and escalate to Country Head or equivalent as appropriate
Ensures that prevailing legislation, GCP, EC/IRB and SOP requirements are fulfilled; identify potentially significant quality / compliance issues and escalate to Country Head or equivalent, as appropriate
Perform reviews of monitoring reports for compliance with SOPs, ensure issues identified are appropriately documented, resolved or escalated
Oversee trial budgets; monitor trial spending and take appropriate actions to facilitate smooth and regular refunds from Basel, and ensure timely and accurate trial cost projections and updates are provided in accordance with set deadlines
Accountable for the accuracy of applicable reporting systems and repositories throughout trial conduct
Performs periodic TMF reviews for quality
Coordinate and facilitate in audits and inspections, in collaboration with lead CRA
Liaise with local/global clinical teams (e.g. unresolved site issues) and the relevant CPO colleagues to enhance Novartis relationship with clinical sites
Managing CRO for outsourced clinical trials, as applicable
May function as a senior/lead CRA, as assigned
Strong interpersonal skills, team player
Strong problem solving, project management and leadership skills
Ability to perform and meet deliverables under pressure
Proficient in negotiation skills and effective in influencing others
Excellent site management capabilities with demonstrated capability to problem solve and mediate complex issues including compliance
Expert knowledge of ICH GCP, international standards (FDA, EMEA) and local regulations
Proven ability to manage teams and complex communication locally and in the global organization

MA Clinical Research Manager SH Resume Examples & Samples

A minimum of a Medical degree or Bachelor’s Degree in Life Science (Animal Science, Biology, Physiology, Nursing, Medical Technology) plus seven (7) years relevant experience, which includes a minimum of three (5) years’ experience in medical device/drug clinical research, and a minimum of (2) years experience managing (indirectly or directly) a professional staff
Master’s degree with a demonstrated research background is preferred
Experience with Good Clinical Practice (GCP) is required. Knowledge of Good Laboratory Practice (GLP) and Good Manufacturing Procedures (GMP) will be an advantage
Prior participation in all facets of clinical studies and prior supervisory experience required
Strong technical or clinical background required
Administering successful programs within a timeline
Effective communication on superior, peer, and subordinate levels
Ability to hire quality professionals
Demonstrated leadership to develop, motivate and guide subordinates to meet objectives
Effective written and verbal communication skills in the area of technical/clinical applications. Strong command of medical and surgical terminology
Demonstrated ability to persuasively influence external medical professionals to ensure project deliverables are completed on time and within budget
Effective analytical and problem solving
Ability to coordinate and lead multiple projects simultaneously
Knowledge of CFDA regulations concerning the conduct of pre-clinical, clinical studies and CER submissions
Knowledge of local, regional, and international regulations for clinical studies is preferred
Effective knowledge in searching medical literature and databases for clinical and technical information
Familiarity with biostatistics techniques and methods is an advantage
Effective skills in MS Excel, PowerPoint, Word and internet search engines
Excellent computer skills and knowledge of computerized databases for the maintenance of scientific data
Working knowledge of statistics and statistical methods
Strong command of Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) regulations
Ability to train others
Ability to work with a minimum of supervision
Ability to work in a highly matrixed team environment
Drive for results
Developing direct reports
Ethics and Values
Functional Technical Skills
Customer Focused
Interpersonal Savvy
Managing and Measuring Work
Building Effective Teams
Ability to train, mentor and develop others

Clinical Research Manager Resume Examples & Samples

5+ years of experience in clinical research
1+ years experience leading project teams or supervising direct reports
Previous experience in a cross-functional role that required understanding of clinical trial methodology and execution
Experience with International Conference on Harmonization (ICH), Good Clinical Practices (GCP), safety and data management requirements, clinical trials management, regulatory compliance (including individual global/country directives/regulations as necessary) and reporting
Experience managing multiple clinical trials from start to finish, including development and execution of comprehensive project plans, timelines, resource and budget planning and management
Experience leading clinical teams in a matrix environment
Experience working with contract research organizations
Talent development and performance management experience of staff at various levels of experience
Masters Degree or Ph.D
Clinical experience in a medical device company specializing in Cardiovascular
Extensive knowledge and research experience in cardiac physiology
Highly developed leadership skills to build and direct clinical project teams to ensure that timeline, cost, and quality metrics are met
Proactive and critical evaluation of all aspects of clinical development to ensure accountability at multiple levels
Ability to work with a continued focus on quality, efficiency and ongoing improvement
Strong problem solving, decision making, prioritization and organizational skills
Ability to lead and motivate others

Clinical Research Manager Resume Examples & Samples

8+ years’ experience managing clinical research studies. (Master’s degree will substitute for 1 year experience; Ph.D. will substitute for 2 years’ experience)
Experience managing global clinical trials; industry sponsored
Experience providing work direction to staff and accomplishing study execution through others
Bachelor’s Degree in engineering, life sciences or related medical/scientific field
Previous personnel management
Working knowledge of Quality System Regulation (QSR 21 CFR 820), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485:2003,Good Clinical Practice(GCP)
Demonstrated ability to cultivate relationships with co-workers in a cross-functional environment

Senior Clinical Research Manager Resume Examples & Samples

Experience managing Investigational Device Exemption (IDE) medical device trials
Cost center/budget management experience
Experience leading and mentoring clinical teams
Bachelor’s degree in a technical field. Technical degree defined as engineering, life sciences or related medical/scientific field
Strong knowledge of monitoring functions
Technical degree preferred
Advanced written, oral, and interpersonal communication skills including proficient knowledge of medical terminology
Strong computer skills (MS Office products, word processing, spreadsheets, etc.)
Strong prioritization and organizational skills
Positive outlook

Clinical Research Manager Resume Examples & Samples

Required: Bachelor's degree in a related discipline
Preferred: Master's degree in a related discipline
Required: Five years of directly related experience. Previous experience in the management and coordination of clinical trials is essential

Senior Clinical Research Manager Resume Examples & Samples

6) Prepare study budget proposal based on fair market value. Ensure the study is operated according to the budget
7) Actively guide and coach CRAs in the study team
8) Coordinate with data management, statistician and medical writer to generate the statistical report and study report
9) Evaluate the CRO, provide evaluation assessment to line manager
10) Perform co-monitoring to team members
1) Provide feasibility assessment and input at project planning stage based on a satisfactory level of technical and professional skill or knowledge in position related areas
2) Provide input on training curriculum based on current developments and trends in areas of expertise
3) Provide local insight on global clinical trials

Clinical Research Manager Resume Examples & Samples

Assists with the design and implementation of research studies, including reviewing protocols, supporting research sites to recruit and retain study participants, and managing study operations and communications
Ensures compliance with government regulations throughout study implementation and when reviewing protocols, informed consent documents, reports, and manuscripts
Conducts site assessments visits to ensure research sites are implementing the study per protocol and to provide guidance for operational management
Excellent oral and written communication skills, including the ability to manage communication from multiple sources and communicate effectively with varied stakeholders (e.g. MTN network leadership, protocol leadership, FHI 360 colleagues, and research site staff)
Ability to analyze and interpret data, identify errors and prepare reports
Knowledge of sexual and reproductive health and HIV
Master Degree highly preferred
Typically requires 3-5 years of research or evaluation experience
Proficiency in Microsoft Office, spreadsheet software and other technology required

Clinical Research Manager Resume Examples & Samples

Manages the day-to-day operations of the Center
Supervises Study Coordinators/Project Managers, Lab Technician, and coordinates with 1 or 2 Clinical MD Fellows regarding task priorities and compliance of Center procedures
Allocates and supervises laboratory human and fiscal resources to meet timelines and productivity goals
Analyzes clinical trial proposals
Determines feasibility of conducting studies from clinical, administrative and financial perspectives
Develops, negotiates, and monitors trial budgets
Designs and implements strategies to successfully perform research trials and assumes responsibility for their timely and accurate completion
Designs and proposes strategic plan for successful study completion including workflow and recruitment
Provides ongoing supervision to assure successful study completion
With the Lab Fiscal Administrator monitors spending and charges on projects and assures appropriate invoicing of sponsors
Develops and implements lab recruitment strategy
Develops and evaluates recruitment strategies to be implemented by Recruitment Coordinator including spending of ~$500/week recruitment budget
Critically analyzes results of recruitment strategies on a continuing basis and implements cost-efficient changes
Responsible for lab quality control and compliance with Hospital, Sponsors, and Federal regulatory requirements
Designs quality assurance systems and implements necessary changes to assure compliance
Oversees the submission and maintenance of regulatory documentation to the IRB and sponsors
Interacts directly with study sponsors, the NIH, and institutional department heads/staff
With Director and Lab Fiscal Adminstrator drafts short and long-range strategic plans for the Center for review with Lab Director
Implements these plans and evaluates their success
Minimum of 7 years of progressively responsible project management experience in a healthcare setting (clinical research preferred)
Prior supervisory experience required
Strong analytical and computer skills including word processing and database management (ACCESS/EXCEL)
Ability to effectively supervise others
Demonstrated analytical skills and ability to logically sequence experiments to maximize research

Clinical Research Manager Resume Examples & Samples

Designs clinical studies in close collaboration with the project leader, Regulatory Affairs (RA) and other stakeholders as appropriate. This includes the setting of objectives, budgets, resources, timelines and the study protocol
Ensures that the study is conducted and reported according to legal requirements, relevant regulatory standard (e.g. GCP, GLP) and the applicable internal policies and procedures
Prepared submission dossiers, in collaboration with Regulatory Affairs, and interacts with relevant regulatory agencies (e.g. FDA, EPA, USDA) to support projects, as required
Develops and maintains a network of clinical and scientific contacts
Minimum of (3) years experience in pharmaceutical or biological research, which may include graduate study in a relevant scientific field
High level of organizational skills
Ability to complete tasks independently while working collaboratively as part of a team
Ability to communicate internally with colleagues representing different disciplines and with external research partners and regulatory agencies
Position may require 50% Travel
Minimum of (3) years experience in animal health clinical research and accompanying familiarity with principles of Good Clinical Practice

Senior Clinical Research Manager Resume Examples & Samples

Bachelor’s degree in engineering, life sciences or related medical/scientific field
Advanced degree (e.g., MS, MA, MPH, PharmD, PhD, DVM or MD) in scientific field of study
Strong knowledge of clinical research study design and outcomes
Advanced project management experience
Expertise in interventional medical device sector and experience managing cardiovascular medical device trials
Medical device industry knowledge
Strong leadership and negotiation skills
Demonstrated ability to execute effectively to achieve business results through motivating and holding individuals accountable to deliverable
Excellent working knowledge of the CFR & GCP
Willingness to accept challenging assignments and engage in relevant development activities

Clinical Research Manager Resume Examples & Samples

Lead in study design discussions to develop appropriate clinical trials to meet the NPD / LCM as needed
Lead in appropriate interpretation and dissemination of all evidence generated, based on EDS, including Clinical Study Reports, abstracts, manuscripts
Develop and deliver appropriate Global EGS / EDS to support NPD and LCM within the assigned platforms, with collaborative relationships with all relevant CR&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics& Market Access, R&D, ensuring cross- functional alignment
Responsible for delivery of assigned clinical projects, through effective partnership with the Clinical Operations and Biostats and Data Management teams, to enable optimized engagement leading to delivery of clinical project commitments in compliance with all applicable regulations and company procedures
Ensure input and strong alignment from key regional MD CR&D leads and other strategically important countries/regions in the development of the EGS / EDS
Contribute in clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, including during sponsor regulatory inspections
Responsible for team’s interface and collaboration with key opinion leaders, investigators, clinical institutions, Regulatory Agencies, societies, associations
Foster strong relationships with external stakeholders to shape and influence relevant policies
Be a subject matter expert in the development of clinical evidence therapeutic areas of interest
Thorough understanding of clinical research science and processes along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations
Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders
Experience in effective management of project budget processes
Ability to apply understanding to help define and shape clinical evidence strategies
Bachelor’s degree in Biological Science or related discipline is required with 8 years of leadership experience within clinical research OR 6 years with a Masters OR 3 years with a Ph.D
Ability to influence, shape and lead without direct reporting authority is required
A successful track record of fostering strong relationships with external stakeholders to shape and influence relevant policies are preferred
Ability to 20% international and domestic

Clinical Research Manager Resume Examples & Samples

Be a subject matter expert in the development of clinical evidence in the cancer / interventional oncology therapeutic areas of interest
Ability to stay current with evolving innovative minimally-invasive interventional oncology device-based therapies, including disruptive technology and associated clinical data
Ability to apply understanding to help define and shape clinical evidence strategies in the interventional oncology space
Demonstrated knowledge of minimally invasive cancer therapies, cancer pathophysiology, and interventional oncology for treatment of various solid tumors is preferred

Clinical Research Manager Resume Examples & Samples

The incumbent is accountable for the performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, MSD policies and procedures, quality standards and adverse event reporting requirements internally and externally
The CRM is the country point of contact (POC) for assigned protocols between ROC and CO and pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments, requiring strong collaboration with local Country Operations roles. The CRM forecasts country resource needs and serves local business needs (signs contracts, manages budgets as delegated)
The CRM is responsible for collaboration and relationship management with investigators for insourced and outsourced studies, with functional outsourcing vendors and other external partners. The CRM oversees country and site validations, site selection and recruitment in assigned protocols
The CRM collaborates internally with GMA/GHH, local PV and Regulatory Affairs to align on key decisions in countries. Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations. The position requires coordination and alignment with the regional and broader organization
The ability to identify problems, conflicts and opportunities early and lead, analyse and prepare mitigation plans and drive conflict resolution is critical. The position requires skilful negotiation in tough situations with both internal and external groups; settle differences with minimum noise; win concessions without damaging relationships; be direct and forceful as well as diplomatic; gain trust quickly from other parties in negotiations and have an excellent sense of timing. Examples of common problems include: 1) low patient recruitment, 2) inadequate staff to meet business needs, 3) performance or compliance issues, 4) working with regulatory issues and the broader organization, and 5) resolution of conflictive situations on country level
Resposible for recruiting new hires, oversees development plans and assigns mentors for new hires. Provides training, support and mentoring to the CRA to ensure continuous development
Oversees appropropriate use of technology (data/information systems, monitoring reports, expense reporting) within area and ensures timley reporting of study information
8-10 years of clinical research experience for a BS/MS/MBA/JD; 3-6 years for an MD-PhD
Strong understanding of clinical trial planning, (site)management and metrics
Strong communication, educational/pedagogic, diplomatic and empathic skills
Strong leadership skills (scientific and business) and proven ability to coordinate and lead local teams to high performance
Ability to lead across several dimensions simultaneously

Clinical Research Manager Resume Examples & Samples

3 years clinical research managerial experience; Prefer 5 years clinical research managerial experience
Coordinate database development, data collection, data entry, data analytics, data reporting, and quality assurance
Coordinate selection of clinical outcomes measurements
Monitors, directs, and supervises staff in a manner that facilitates efficient level of operations
Prepares and conducts employee hiring interviews for appropriate positions and writes justifications for new position requests
Makes appropriate salary recommendations for new and existing staff and conducts annual staff performance reviews
Strong skills in various technologies including but not limited computer software (Microsoft Office), electronic medical records systems, digital radiographic imaging systems, and mobile technologies
Ability to analyze large datasets in order to identify illogical or suspicious research data
Knowledge and understanding of the informed consent process for prospective research studies involving human subjects
Coordinate submissions to regulatory bodies, including but not limited to IRB, FDA, and NIH
Ensure all research team members comply with all regulatory requirements
Independently critique study proposals and idennity conflicts, obstacles, or issues that may delay or prevent successful completion of projects
Oversee training of staff to ensure full compliance with study protocol
Assist in coordinating research projects
Systematically maintain and organize paper and electronic research study documents
Develop appropriate timelines to ensure timely completion of assigned projects
Work effectively with members of the research team to resolve issues interfering with completion of projects
Assist with the submission of research abstracts and related material to professional meetings
Assist with developing presentation materials, meeting agendas and annual reports as needed
Demonstrate initiative, good judgment, organization and attention to detail
Independently manage work schedule to best utilize time and skills without direction from others
Recognize and perform unassigned duties as needed
Regularly assist and/or train others as need is perceived

Oncology Clinical Research Manager Resume Examples & Samples

The incumbent is accountable for the performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Merck policies and procedures, quality standards and adverse event reporting requirements internally and externally
The CRM is the country point of contact (POC) for assigned protocols between Region and Country Operation and proactively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments, requiring strong collaboration with local Country Operations roles
The CRM forecasts country resource needs and serves local business needs (signs contracts, manages budgets as delegated)
The CRM is responsible for quality and compliance for assigned protocols in the country and oversees CRAs and/ or CTCs and training compliance. Performs quality control visits, reviews Monitoring Visit Reports and escalates performance issues and training needs to functional vendor and internal management as needed
The CRM is responsible for collaboration and relationship management with investigators for insourced and outsourced studies, with functional outsourcing vendors and other external partners
The CRM oversees country and site validations, site selection and recruitment in assigned protocols
The CRM is responsible for clinical trial education to sites, and acts as the country POC for programmatically outsourced trials for assigned protocols. In collaboration with CRD, represents Merck/MSD in Pharma industry issues and in seeking influence in external R&D environment
The CRM collaborates internally with GMA/GHH, local PV and Regulatory Affairs to align on key decisions in countries
Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations. The position requires coordination and alignment with the regional and broader organization
Examples of common problems include
Strong understanding of clinical trial planning, (site) management and metrics
Excellent oral and written English language skills
Problem solving and conflict resolution
Has demonstrated the following leadership behaviors

Asst Clinical Research Manager Resume Examples & Samples

Oversees registration of protocol patients with QACT, study group registrar and pharmaceutical company as outlined in protocol
Assumes responsibilities for data management. Maintains schedules and procedures necessary for timely and complete data collection
Oversees and coordinates the purchase, receipt, inventory and distribution of equipment utilized in the conduct of clinical trials
Minimum of 3-5 years of related experience preferred
Must have the ability to function independently, with little supervision
Computer skills including the use of Microsoft Office

Clinical Research Manager Resume Examples & Samples

LI-NS1
Extensive experience in the pharmaceutical/medical field with at least 5 years of clinical trial management/monitoring experience recommended
A scientific/healthcare related degree
Relevant therapeutic area experience (preferred)
Strong project leadership skills
Effective team building and teamwork skills
Knowledge of SOPs/regulations relevant to clinical research in Switzerland
Fluency in written and spoken German, English and French

Clinical Research Manager Resume Examples & Samples

The incumbent is accountable for the performance for assigned protocols in a country in
The CRM is responsible for collaboration and relationship management with
8-10 years of clinical research experience for a MS/MBA/JD; 3-6 years for an MD-PhD
Experience in management of Trails in CNS in strogly preferred
Has demonstrated the following leadership behaviours

Clinical Research Manager Resume Examples & Samples

Bachelor's degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
Minimum of 5 years’ experience in the pharmaceutical industry, at a CRO or hospital including clinical research experience. Effective communication and leadership skills and ability to foster team productivity and cohesiveness
Experience mentoring/coaching others. Experience with people management is desirable. Ability to lead hiring, training, development and evaluation of people. Solid decision-making and financial management skills
Strong knowledge on drug development, clinical research operations and regulatory requirements including GXP, ICH and local regulations or FDA CFRs (if applicable). Strong ability to synthesize and evaluate data generated from various reports and sources

Clinical Research Manager Resume Examples & Samples

The CRM is the country point of contact (POC) for assigned protocols between ROC (Regional Operations Center that is in charge of Project Management) and country operations and pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments, requiring strong collaboration with local Country Operations roles
The CRM is responsible for quality and compliance for assigned protocols in the country and oversees CRAs and training compliance. Performs quality control visits, reviews Monitoring Visit Reports and escalates performance issues and training needs to functional vendor and internal management as needed
The CRM is responsible for clinical trial education to sites, and acts as the country POC for programmatically outsourced trials for assigned protocols. In collaboration with CRD, represents MSD in Pharma industry issues and in seeking influence in external R&D environment
The CRM collaborates internally with Medical, Business, pharmacovigilance and Regulatory Departments to align on key decisions in countries. Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations. The position requires coordination and alignment with the regional and broader organization
Master in Science (or comparable). Advanced degree (MD, PhD) possible but not required

Clinical Research Manager Resume Examples & Samples

Responsible for conducting Nobel Biocare Sponsored Studies as well as supporting Investigator Initiated Studies
Responsible for the design, implementation, monitoring, supervision and direction of clinical studies
Identifying/selecting investigators who will be responsible for conducting studies
Responsible for running investigator’s meetings
Responsible for study site visits and meeting research objectives
Managing compliance and protocol activities
Developing and writing clinical study protocols
Designing data collection forms, known as case report forms ( CRFs)
Organizing ethics committee submissions with the study sites
Managing regulatory authority applications and approvals when applicable
Managing statistical evaluation of study results with the support of independent statisticians
Supporting other departments with clinical content and knowledge

Clinical Research Manager, Assoc.director Resume Examples & Samples

1) low patient recruitment,
2) inadequate staff to meet business needs,
3) performance or compliance issues,
4) working with regulatory issues and the broader organization, and 5) resolution of conflictive situations on country level
10 years clinical research experience is a minimum requirement
Specific Experience
Project management experience with positive records of success
People management experience is desirable
Profound expertize in Clinical Study oversight and Site management

Clinical Research Manager Resume Examples & Samples

MA/MS, Doctoral or higher degree in related field
Prior experience conducting semi-structured and structured clinical interviews in children (e.g. Kiddie Schedule for Affective Disorders and Schizophrenia, Children's Depression Rating Scale, Pediatric Anxiety Rating Scale, and Young Mania Rating Scale) and adults (e.g. Structured Clinical Interview for DSM) and experience with good clinical practice (GCP) guidelines
Experience running NIH sponsored research studies
Necessary patience and ability to work with children and their families

Clinical Research Manager Resume Examples & Samples

Use effective training tools to integrate clinical studies into clinic daily operations in order to minimize study deviations and maximize patient participation opportunities
Facilitates timely issue escalation and resolution for study teams and clinic issues as it relates to clinical research execution
Facilitates facility teammate training and clinical study execution to ensure the effective execution of research tasks performed by the clinic staff
Understands and promotes compliance with all applicable healthcare and research regulations
Coordinates with Quality Assurance to ensure teammates are trained on Standard Operating Procedures, research regulations and applicable healthcare regulations
Participates in Central Sites operations review on a quarterly basis
Assists the Director of Clinical Research Integration in preparing monthly operational updates for senior leadership
Other duties assigned
BS/BA required. Science area of study preferred
Minimum five (5) years of Clinical Research Experience or equivalent experience
Ability to manage multiple projects, meet deadlines, and adjust priorities appropriately in an evolving work environment with shifting time frames; self-starter with high degree of initiative, urgency, and follow through
Innovative, analytical thinker with demonstrated ability to perform root cause analysis, prepare and implement action plans, and lead improvement initiatives
Travel required, less than 50%

Clinical Research Manager Resume Examples & Samples

Accountable for the performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, MSD policies and procedures, quality standards and adverse event reporting requirements internally and externally
Responsible for quality and compliance for assigned protocols in the country and oversees CRAs and/or CTCs and training compliance. Performs quality control visits, reviews Monitoring Visit Reports and escalates performance issues and training needs to functional vendor and internal management as needed
Responsible for collaboration and relationship management with investigators for insourced and outsourced studies, with functional outsourcing vendors and other external partners. The CRM oversees country and site validations, site selection and recruitment in assigned protocols
Collaborating internally with Medical Affairs, local PV and Regulatory Affairs to align on key decisions in countries. Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations. This position requires coordination and alignment with the regional and broader organization
Master in Science (advanced degree (MD, PhD) possible but not required)
8-10 years of clinical research experience for a MSc; 3-6 years for a MD-PhD
Negotiation skills with both internal and external stakeholders
Excellent oral and written Dutch and English languages skills

Clinical Research Manager Resume Examples & Samples

Manage and oversees the operational execution of sun care and foot care studies in humans. This includes but is not limited to the guidance and management of internal and external CRAs
Manage and oversee the activities of CROs and other operational contractors and third parties involved in the conduct of CH studies. This includes that the incumbent ensures that all applicable guidance’s including, however not limited to ICH Guidelines, GCP and SOPs are followed in all aspects of the studies
Select and qualify study sites, conduct pre-study visits, study initiations, carry out interim monitoring visits with the timely completion of reports and oversee these activities
Develop or contribute to protocol development as necessary
Manage the timelines and budgets of the assigned studies
Education: Bachelor’s degree or related degree in Life Sciences, Health Sciences or related field, or a professional nursing or medical qualification
Experience: Minimum of 5-6 years’ experience in clinical biomedical development, preferably with 2-3 years’ experience managing the operational part of clinical studies
Excellent written and verbal communication skills, interpersonal and organizational skills
Good knowledge in in tracking clinical study costs against the budget
Knowledge of, and adherence to ICH/GCP Guidelines, and as well as appropriate guidelines for clinical monitoring
Broad knowledge and cross functional understanding of clinical trial methodology and logistics
Competencies: Team player with ability to work independently to accomplish objectives within timelines established by the Clinical Trial Manager and /or Project Teams, and the ability to work in a matrix organization

Clinical Research Manager Resume Examples & Samples

Applies critical thinking skills and utilizes quality data and conceptual knowledge in the development of the department vision and operational plan. Hires clinical research staff and has responsibility for delegating tasks, monitoring workloads, and evaluating job performance. Oversees the day-to-day activities of the clinical research program and provides direct supervision to the clinical research staff. Serves as liaison between study sponsors and PIs; serving as the key coordinator for multi-center trials involving subject enrollment. Demonstrates the ability to create a shared vision applies critical thinking skills and utilizes financial and quality data and conceptual knowledge in the development of the department vision and operational plan. Orchestrates complex change and acknowledges the psychological transition on self and others. Involves stakeholders and experts in planning, designing, and redesigning change. Accountable for the recruiting, retaining, and developing of clinical research staff
Creates developmental paths to increase the expertise of staff. Initiates innovation in staff development, clinical orientation, continuing education, and supports specialty certification. Develops strategies to maximize timely completion of disease center specific CRFs and data collection forms within standard of practice guidelines. Monitors and facilitates completion of all protocol required data elements within CTMA and ensure all electronic data capture is complete and accurate Develops strategies to ensure protocol compliance and patient safety. Demonstrates a passion for developing others, enthusiastically and expertly precepts new hires during the orientation process and serves continuously as a mentor. Takes responsibility for identifying his or her ongoing professional development needs and independently seeks resources and opportunities to meet those needs, such as through membership in nursing, oncology, or research organizations
Ensures that staff practices in accordance with established Good Clinical Practice guidelines. Assists in institutional review board (IRB) document preparation and submission. Supports and assist in research coordination for high profile/high risk clinical trials. Creates a caring and compassionate patient focused experience by building healing relationships with patients, families and colleagues. Disseminates new knowledge and innovations through presentations, posters, and publications. Practices solid communication skills and is able to articulate and translate pertinent patient, protocol and staff information
Establishes and maintain a collaborative working relationship with all ancillary departments and staff. Develops and maintains productive working relationships internally and externally by building teams and relationships through mentoring and modeling uplifting and positive communication. Note: The above statements are intended to describe the general nature and level of work being performed by people assigned this job. They are not exhaustive lists of all duties, responsibilities, knowledge, skills, abilities and working conditions associated with the job
Monitors dashboard and quality indicators to meet organizational goals and develops and implements new processes to address specific concerns and improve quality. Supports and encourages staff involvement in the development and implementation of quality improvement initiatives. Assists in the development of departmental standards of practices
Three years (3) of nursing experience required
Minimum of 3 years progressive leadership experience required
Relevant clinical experience in either oncology or research preferred
BSN required
Masters degree in Nursing or related health care field preferred
Must be able to demonstrate the knowledge and skills necessary to provide care and/or interact appropriately to the ages of the patients served by the department Must have excellent organizational skills, meet requests from multiple individuals, and respond appropriately to sudden workload changes. Must possess excellent presentation skills and written and verbal communication skills
Knowledge of the adult learning principles
Solid/strong/good or higher on most recent performance evaluation and maintained in current practice

Clinical Research Manager Resume Examples & Samples

Ph.D. in the social sciences with an emphasis on disparities-related fields, such as medical sociology, anthropology, or epidemiology
Five years of experience in administration and teaching preferred
Preferred candidates will have established recognition in diabetes health equity initiatives or committees at the state and national levels, and experience with education curriculum development an accreditation

Senior Clinical Research Manager Resume Examples & Samples

Responsible for the day to day management of clinical trials
Manages activities performed by direct reports, consultants and/or Contract Research Organizations
Demonstrated ability to manage people
Managing clinical trials, or equivalent project management experience for at least 3-5 years
Proficient in GCP, ICH guidelines and other US and international clinical regulatory requirements
Experience in IVD is preferred

Clinical Research Manager Resume Examples & Samples

Lead the clinical study design proposal contributions for all projects between key stake holders
Lead clinical study design inputs into the study plan to support approval of governance approved product label
Ensure compliance of all clinical study activities with required global, regional and local regulatory and quality requirements and internal Regulatory/Research & Development and quality policies
Lead the clinical study plan contributions on global Research & Development project teams as required
Develop and lead the personal and professional development programs of clinical team personnel
Lead the Clinical Studies team in the development of clinical study protocols, all clinical research contracts and assist conducting pivotal clinical studies as required
Lead the execution of any global clinical studies required for the Oceania region Lead the development of the Clinical Procedure documentation and Clinical Quality SOP system
Lead the clinical contributions in the development of the project scoping document; and
Lead all ORD clinical program communications to local, regional and global stakeholder groups
Bachelor Science/Animal science or equivalent) or Bachelor of Veterinary Science
History of leading Clinical studies, exposure to data audit, and data analysis in sheep/cattle/dog/cat parasitology studies is essential
Comprehensive understanding of the principles of industrial operations and Animal Health regulatory processes is essential
Experience in managing large scale dairy studies highly desirable
Experience in managing biological clinical studies highly desirable; and
You must be meeting performance expectations in your current role

Stem Cell & Gene Therapy Clinical Research Manager Resume Examples & Samples

Early Phase, biologics and/or stem cell clinical trial experience strongly preferred
Previous supervisory experience preferred
Strong organizational and project management skills desired
Proficiency in Microsoft Office and database applications
Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices
Demonstrated managerial experience

Clinical Research Manager Resume Examples & Samples

Supervise clinical research staff for all aspects of conducting a complex and multi-site clinical study
Develop and implement plans, schedules, and standard operating procedures under the guidance of study leadership for assigned sites
Collaborate effectively with others to ensure proper progress in enrollment milestones and completion of studies
Participate in local and national collaborative calls related to program operations
Train new staff in preparation and conduct of clinical trials and protocol specific operations
Supervise and provide oversight and guidance as needed to research staff; Supervise activities of subordinates, if assigned
Collect and process specimens to meet study requirements, including saliva, urine and intravenous blood samples
Provide oversight for the preparation, review, submission and maintenance of regulatory activities/submissions within our team to the national IRB, ensure accuracy and timeliness of distributing regulatory updates to all collaborative parties
Implement successful plan to identify potential participants
Determine best method/s to identify potential participants for research protocol (advertisements, chart reviews, monitoring of clinic schedule, etc.) and prepare accordingly
Maintain a detailed tracking system for participants considered for enrollment. Track progress at regular intervals and report out to PI and study team
Proactively take initiative to ensure enrollment stays on track with the project timelines
Maintain master files for clinical research protocols
Master’s degree in a field appropriate to the area of assignment AND three years related research experience; OR, Bachelor’s degree in a field appropriate to the area of assignment and four years related research experience; OR, Any equivalent combination of experience, training and/or education
Previous human subjects training (e.g., CITI certification) and four years’ experience in clinical research with direct recruitment and enrollment responsibilities
Ability to work both independently and with a team, resolving issues with a positive outcome

Clinical Research Manager Gastrointestinal Service Resume Examples & Samples

Staff Management: Supervise the training/development and performance management for direct and indirect reports throughout the service
Protocol Development: Oversee all aspects of the protocol development process including protocol, consent and other essential study document drafting. Must be able to write protocols
Financial Management: Works closely with the appropriate stakeholders, forecast trial resource needs, and assesses staffing resource needs for program and senior leadership to ensure appropriate line function allocations
Quality Assurance: participate in routine audits for data quality, regulatory compliance, patient safety issues related to clinical trial. Communicates and ensures compliance with company policies and procedures, quality standards and improvement initiatives

Clinical Research Manager Resume Examples & Samples

Marian Hospital Medical Center (Santa Maria, CA)
Arroyo Grande Hospital (Arroyo Grande, CA)
French Hospital & Medical Center (San Luis Obispo, CA)
Pacific Central Coast Clinics (Santa Maria, CA)
St. John’s Hospital (Oxnard, CA)
Bakersfield Memorial Hospital (Bakersfield, CA)
Mercy Merced Hospital (Merced, CA)
A minimum 3 years of full-time experience in research administration in a hospital or clinic setting or closely related field required
Combination of 3 or more years experience in clinical trial budget preparation, research personnel management or general health related business management required
A thorough understanding of regulatory requirements related to the oversight of research by Institutional Review Boards
A minimum 3 years of experience in clinical research, or closely related discipline required
Thorough knowledge of fiscal planning, principles and techniques of administrative management including organization, planning, staffing, training and reporting
Knowledge of GCP, ICH, Federal, State and other general regulatory research oversight requirements
Scientific writing and grant development experience preferred
Demonstrated ability to work with all members of the research community including principal investigators, clinical coordinators, students and all levels of hospital administration and clinical program management
Ability to interpret research protocol information in relation to completing a Medicare Coverage Analysis, developing clinical trial budgets, understanding federal regulations/guidelines, and institutional policies
Exercise sound judgment and make recommendations and/or decisions regarding research policies and procedures
Experience with web based IRB submission and IRB management applications and tools. Advanced experience using spreadsheet, database and word processor applications as well as computerized tracking systems
Effective organizational skills; effective follow-through, and commitment to excellence
Ability to produce timely and competent work with minimal supervision
Take a leading role in the refinement of the service area and facility research mission, strategic and business plans in support of current and future research programs
Support and promote existing research programs including Cardiology, Interventional Cardiology, Oncology, Neuro/Stroke, student and data research
Assist the facility Accountable Executive for Research by developing, planning, analyzing, evaluating, advising, implementing and directing specific departmental activities with the goal of maximizing efficiency of various management control systems, programs, policies, work methods and procedures
Collect and analyze data to develop specific recommendations and advice for changes in work operation and other key actions for the purpose of improving the efficiency, quality of programs, fiscal accountability and operations management
Collaborate regularly with Research Institute management, IRB staff and research manager staff. Attend monthly Research Institute and IRB meetings as necessary
Execute institutional policies and procedures to ensure Dignity Health’s compliance with Federal, State and other regulations governing the conduct and management of research
Proactively seek new research opportunities and provide community outreach regarding the service area and facility research programs and research capabilities
Seek opportunities to collaborate with other Dignity Health facilities to expand research program collaborations beyond the facility and service area
Establish research budgeting and financial reporting procedures including monitoring and controlling research study specific and general research program expenditures
Administer a general research support services budget including a cost effective mix of industry (commercial), government, grant, hospital foundation and investigator sponsored research
Establish appropriate procedures to monitor hospital and investigator compliance with sponsor clinical trial agreements, grant awards and other research related financial agreements
Invoice research sponsors for administrative and other costs as necessary in the review of new and ongoing research
Act as liaison between all members of the service area research community including Physicians/Principal Investigators, facility Accountable Executives, facility Administration, Dignity Health Research Institute, IRB Chair, IRB committee members & staff, Dignity Health Legal, Dignity Health Corporate Compliance and government agencies
Monitor the progress of research activities; develops and maintains records of research activities, and prepares periodic and ad hoc reports, as required by investigators, administrators, funding agencies, and/or regulatory bodies
Develop appropriate training/educational materials along with the Dignity Health Research Institute for all members of service area research community
Responsible to work with the Dignity Health Research Institute to identify and develop efficient processes for general administrative oversight to increase productivity and provide improved services overall to the service area research community
Coordinate outreach and research support services with the hospital's charitable foundation with regard to seeking research funding and grant opportunities
Meets all mandatory requirements of the position including mandatory training, classes, licensure/certification, employee health requirements, and adherence to Dignity Health's Code of Conduct
Other job skills required: Demonstrates appropriate time management skills. Demonstrates effective verbal and legible written communications and interpersonal skills with associates, community and other customers. Provides accurate and helpful information and instructions to departmental and hospital customers. Accurate listening skills while checking understanding, with appropriate follow through on requests for information and/or services

Site Clinical Research Manager Resume Examples & Samples

Bachelor’s Degree in a related healthcare, science or administration field, required
Minimum of three (3) years relevant experience as a clinical research associate or clinical research coordinator. Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA) or equivalent certification, preferred
Sound knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs
Solid teamwork, organizational, interpersonal, and problem solving skills
Ability to multi-task, work under time constraints, work independently and cooperatively with interdisciplinary teams

Clinical Research Manager Resume Examples & Samples

Manages a Practices clinical research program and operations in accordance with USON SOP and ICH GCP guidelines. Responsible for ensuring at the administrative level that all research activities are coordinated with affected departments within the practice
Collaborates with the Site Research Leader (SRL), physicians of the practice and research committee in the process of study selection for the research program. Develops and implements research budgets that include accrual targets and financial objectives for each research location, in collaboration with practice management. Responsible for promoting or marketing research programs to the practice, community and referring physicians. Coordinates research activities with other (non-USOR) bases or sponsors
Leads meetings and facilitates groups to achieve desired results. Utilizes facilitation tools to ensure participation, innovation and decision-making among group; effectively uses group process techniques
Develops and implements short term goals that align with the companys vision and business goals. Cascades goals down to staffs annual objectives
Develops and maintains current policy and procedural manual and communicates plans appropriately throughout the organization. Coaches and develops staff. Provides on-going job related education and training of staff. May develop training materials
Responsible for the recruitment, interviewing, recommending hires, assessing performance, recommending salary changes, progressive discipline, and retention of staff. Enforces adherence to USON policies
Other duties as requested or assigned

Clinical Research Manager Resume Examples & Samples

Specialty/Department/Practice –Oncology Research
Shift/Schedule – Day Shift
Bachelor’s Degree or equivalent required
4 years of experience required
RN license preferred, CCRC certification preferred

Clinical Research Manager Resume Examples & Samples

Theoretical knowledge of a biological science such as Biology, Microbiology or a related field
Extensive experience and expertise in conducting clinical trials. Proven experience in research protocol start up procedures, marketing, outreach, recruitment, and screening of research subjects. Preferred at least 3 years’ experience
Demonstrated ability to take patient history, evaluate patient problems and provide complete documentation in patient record
Demonstrated ability to develop and implement effective patient scheduling/appointment system and coordinate the flow or necessary documents and referral services
Demonstrated experience collecting, evaluating, and interpreting routine standard lab tests on human subjects, i.e. blood tests, vital signs. Ability to read and interpret lab results and summarize scientific data. Experience processing and shipping human blood samples for onsite and offsite labs
Extensive experience using EPIC
Experience supervising or providing work direction to other researchers in a lab environment
Demonstrated knowledge of research methods in Cardiac Electrophysiology preferred
Advanced skills in data analysis, presentation and publication in journal articles
Demonstrated knowledge of medical billing and collections guidelines and procedures

Clinical Research Manager Subspecialty Medicine Resume Examples & Samples

Staff Management: Supervise the training/development and performance management for direct and indirect reports throughout the programs
Clinical Trial Reporting: Generate protocol portfolio status reports for key stakeholders. Implements solutions for streamlining and accelerating the monitoring and review of clinical trials to significantly increase accrual to clinical trials, data cleaning, data quality, and trial completion
Database Management: Oversees data management aspects of research databases such as the Clinical Research Database (CRDB), department specific patient databases, and the Disease Management System (DMS) as needed

Clinical Research Manager Resume Examples & Samples

Address and resolve all internal and external issues related to site management for assigned research projects
Participate in investigator meeting and/or investigator and site training sessions (as applicable)
Oversee and ensure efficiency of the clinical trial start-up process
Prepare for and respond to internal and external sponsor audits
Over see close-out procedures, including financial reconciliation of all revenue and expenses
Manage staff in accordance with organization's policies and applicable regulations; responsibilities include planning, assigning and directing work flow; appraising performance, guiding professional development and mentors new research team members
Participate in the selection and on boarding process for new associates by conducting candidate review and participating in the interviewing process; assist with the on boarding training for new associates in conjunction with Human Resources and Sr. Leadership
Use the Clinical Trial Management System (CTMS) to track metrics, timelines and other data to assure quality, timelines and budgets are managed according to expectations; alerts the research team(s) and leadership of significant risks (with mitigation plan) and potential delays (with action plan)
Review and develop a familiarity with the contract or award terms and conditions; works with investigator to assure that the study is in compliance with all terms and conditions, health and safety protections for research participants, and any financial terms and conditions
Contribute to business development activities and participate in proposals as applicable; promotes growth and ensure operational profitability
Liaise and work effectively with multidisciplinary, ancillary, inter-professional research teams, sponsors and IRB to maintain accurate communication of costs, policy changes, fiscal requirements and other regulatory issues
Communicate effectively to the research team regarding the scientific center goals and the importance of serving our customers
Must possess in-depth knowledge of Good Clinical Practices (GCPs) provided by the International Conference on Harmonization (ICH)
Consistently demonstrate support for compliance in the performance of job duties and responsibilities by a) developing and maintaining knowledge of, and performing job functions in compliance with rules, regulations, policies and statutes that affect his/her job; b) maintaining knowledge of and performing job functions in compliance with MedStar Health and MedStar Health Research Institute policies and procedures; and c) reporting compliance concerns in an appropriate and timely manner

Clinical Research Manager Resume Examples & Samples

Directs the Clinical Research operations in administrative, budgetary and fiscal matters, preparing analysis as required for immediate and long range management planning
Manage resources of assigned Clinical Research multiple areas to accomplish specified goals/objectives
Responsible for coordinating activities administered by the research program or service area and in the development and implementation of procedures for the Clinical Research in multiple program/service area
Responsible for assisting in the interpretation and implementation of policies and procedures as they apply to assigned areas of responsibility. May recommend changes on policy/procedures as necessary
Daily supervises research coordinators and support staff engaged in the carrying out of research and clinical protocol
Coordinates special studies or projects as directed by the Assistant and Director of the program
Acts as liaison between program/service sand outside agencies and general public
Performs related duties as required or deemed appropriate to the accomplishment of the responsibilities and functions of his/her area
Plans and directs clinical research activities for an assigned section for multiple clinics across UF Health
Participates in promoting Human Subjects Protections within Clinical Research areas locally and within the state
5 years Clinical research experience in Cardiology/Stem Cell Area
Ability to communicate effectively with medical and research staff, patients and families
Strong computer skills and demonstrated ability to work accurately in a detail-oriented,busy medical environment
Bachelors in Nursing

Clinical Research Manager Thoracic Medicine Resume Examples & Samples

Staff Management: Supervise the training/development and performance management for a large team of direct and indirect reports throughout the programs
Protocol Development: Oversee all aspects of the protocol development process including protocol, consent, budget and other essential study document drafting. Must be able to write protocols and develop budgets
Financial Management: Works closely with the appropriate stakeholders, forecast trial resource needs, and assesses staffing resource needs for program and senior leadership to ensure appropriate line function allocations. As needed, assist the PI and Grants Mgmt. Specialist to help with financial information for grant preparation

Clinical Research Manager Resume Examples & Samples

Act as a resource for investigators and support staff on pre-trial functions including budget development, contract negotiations and IRB applications. Advise department study investigators and support staff on administrative and regulatory aspects of human subject research
Project (protocol) management. Act as liaison to the Faculty Disease Committees and Principal Investigators to ensure a collaborative atmosphere and guide the processes for protocol approval providing research support and management as appropriate following current MCW and Cancer Center CTO policy, procedures and guidelines
An active member of CTO Leadership team with focus on collaboration and continuous process improvement
Manage the disease team resources to provide adequately trained staff, project staffing needs, assign projects, and monitor staff performance
Develop and implement department policies, procedures and organizational tools to ensure compliance with MCW, state and federal standards
Manage data systems supporting research activities including, but not limited to, EPIC, OnCore and eBridge. Correspond with IRBs as needed
Assist in the development and management of budget
Recruit and train clinical research staff nurses and clinical research coordinators; develop and implement standardized expectations for all subordinates; assess, monitor and evaluate work load and performance. Mentor and direct staff to achieve research goals following all relative policies, procedures and guidelines
Assist in process development and support for the ongoing implementation and use of the clinical trial management system, OnCore
Act as a liaison between Cancer CTO Administration and research staff. Work closely with other departments and external agencies to advance the department’s research goals. Collaborate with MCW Office of Research, Grants and Contracts, IRB and other offices and committees to define processes and insure consistency
Serve as primary site contact for Foundation Trials or NCI Cooperative Group as appropriate
Develop, implement and monitor department research QI activities. Implement and conduct quality control processes to ensure the highest data and research standards
Develop clinical review data review plan and check specifications. Utilize quality improvement tools & statistical process control to facilitate improvement of systems & processes
Perform as a Research Nurse/Study Coordinator for select projects and/or patients

Oncology Clinical Research Manager Resume Examples & Samples

The CRM is the country point of contact (POC) for assigned protocols between Trial-level and Country-level Operation and proactively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments, requiring strong collaboration with local Country Operations roles
The CRM is responsible for quality and compliance for assigned protocols in the country and oversees CRAs and/ or CTCs and training compliance
Performs quality control visits, reviews Monitoring Visit Reports and escalates performance issues and training needs to functional vendor and internal management as needed
The CRM is responsible for clinical trial education to sites, and acts as the country POC for programmatically outsourced trials for assigned protocols
In collaboration with CRD, represents Merck/MSD in Pharma industry issues and in seeking influence in external R&D environment
The ability to identify problems, conflicts and opportunities early and lead, analyses and prepare mitigation plans and drive conflict resolution is critical
The position requires skillful negotiation in tough situations with both internal and external groups; settle differences with minimum noise; win concessions without damaging relationships; be direct and forceful as well as diplomatic; gain trust quickly from other parties in negotiations and have an excellent sense of timing

Assistant Clinical Research Manager Resume Examples & Samples

Identifies operational, logistical, and regulatory challenges related to the conduct of clinical trials and acts as a leader in overseeing their resolution
Oversees processing of protocols through DFCI Institutional Review Board (and other institutions' IRBs) when appropriate. Oversees regulatory process for related studies. Collaborates with the Office for Human Research Studies (OHRS)l, the Quality Assurance for Clinical Trials (QACT), and the Clinical Trials Office (CTO) to fulfill federal requirements governing human clinical trials. Completes all annual review requirements
Collaborates with the DFCI QACT to develop study forms, database information, and to establish guidelines for monitoring data quality control
Oversees study enrollments and appropriate protocol treatment and follow-up care for patients in clinical trials
Assists the principal investigator in developing the protocol budget, in collaboration with Research Administration and the Grants and Contracts offices. Work with grant managers and other financial managers in the reporting and accounting of these funds
Responsible for the recruitment and oversight of coordinator staff as well as ensures that staff has completed mandatory training in a timely manner. Develops and oversees a program specific on-boarding and orientation process and participates in annual performance evaluations and competency assessments of research staff
Assists the principal investigator in preparing manuscripts for publication
Provides in-service training and serves as a resource to other clinical personnel including physicians, nurses, pharmacists and other allied health professionals regarding clinical trials, protocols, GCP guidelines, federal regulations and site SOPs

Clinical Research Manager Resume Examples & Samples

Interaction with Sponsors/CROs, IRBs, patients/subjects, nursing and medical staff of various clinics, hospitals and physicians’ offices
Able to perform Clinical Research Coordinator role
Coordinate multiple and complex protocols
Provide a leadership role in developing, implementing and evaluating the conduct of studies
Oversee and supervise the startup, conduct and close-out of studies assigned to the team
Provide quality control review of subject/patient charts, data collection, data entry and data integrity for all studies assigned to the team

Clinical Research Manager Resume Examples & Samples

Bachelor's degree in related area and at least two years of supervisory experience
Two or more years of clinical research or regulatory affairs experience, Solid understanding of clinical trials policies, procedures, and regulatory issues. Experience and knowledge of IRB policies and procedures as well as FDA regulations relating to Investigational New Drugs
Working knowledge of clinical or laboratory research, clinical trial recruitment, eligibility, protocol adherence, quality data submission and adverse event reporting
Broad knowledge of clinical research concepts, federal, state and local laws and regulations, and industry requirements regarding the proper conduct of clinical trials. Broad theoretical and operational knowledge of clinical and patient safety standards and regulations relating to clinical research
Broad knowledge of all phases of clinical research, from study startup through closeout and primary publication and presentation. Knowledgeable about clinical studies involving complex trial design issues
Critical thinking skills to evaluate issues and identify a potential solution
Professional attitude. Ability to respond well to changing priorities. High degree of motivation and innovation; commitment to excellence
Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities
Ability to perform all commonly applicable functions in word processing and spreadsheet software. Effectively uses campus' clinical information and documentation application programs. Proven ability utilizing clinical trial management systems
Ability to work independently. Ability to respond well to changing priorities
Demonstrated management skills supervising, maintaining and developing clinical staff within the study team, and acting as a mentor for professional staff and conducting reviews and performance evaluations. Effectively manages multiple important priorities
Demonstrated ability to work collaboratively with other cross-functional teams and people with a wide range of educational backgrounds. Demonstrated ability to interface with commercial, regulatory, federal and other members of an extended study team. Ability to influence / persuade
Demonstrated ability to organize research work functions in an efficient and effective manner. Great organizational skills applied to personal work and improving organization of assigned staff and trial
Good interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership, mentorship. Interpersonal skills to effectively motivate others. Works well with others to achieve common goals. Ability to cultivate relationships with multiple stakeholders at various levels of administration
Good communication skills; both verbal and written. Clear and concise communicator
Master's degree in related area and / or equivalent experience / training
GCP / Human Subjects Protection certification

Clinical Research Manager Resume Examples & Samples

Five years of clinical research experience in an academic health center, pharmaceutical, biotechnology, or CRO industry or equivalent
Clinical Research Certificate
Ensures work is done on time in a high quality manner
Knowledge of clinical pharmacology and pathophysiology, and food allergy research
Demonstrated excellence in complex project management and effectively managing multiple projects/priorities
Experience managing cross-functional teams or work groups as well as direct reports
Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials
Strong regulatory knowledge and ability to perform monitoring of CRFs, GCP and GMP. This position must know IRB regulations and how to perform IRB submissions. Working knowledge of FDA procedures as applicable, and ICH-GCP and relevant SOPs
Disciplined work approach with the ability to function independently, take initiative and effectively problems solve issues
Customer service oriented both internally and externally with strong organizational, interpersonal and communication skills

Clinical Research Manager Resume Examples & Samples

Risk management process
Full support of Regulatory / Clinical Strategy, including
Preparation of clinical knowledge scientific documentation
Development and execution of Post-marketing clinical plan
Planning and execution of clinical trials according to GCP and following company SOPs including
Contract negotiation with site
Maintaining and improving relationships with physicians/investigators
Preparation of trial related documentation
Organizing Ethics committee submissions
Performing study initiation’s visits, site monitoring and training
Data collection, analysis and reporting
Collaborating with physicians towards publication of study results
Scientific and strategic evaluation of ISTs, request from grants, etc
Lead the clinical knowledge in a specified field (platform) thus providing clinical evidence, training and support to Lumenis members and sites
Responsible for Medical Information responses concerning the specific platform for internal as well as external customers
Active participation in scientific meetings / lectures / congresses
Support Business Units activities from the scientific/medical point of view in strategic thinking, planning and execution
Support vigilance report review with professional, clinical knowledge
Budget management

Clinical Research Manager Resume Examples & Samples

Manage clinical study personnel focused on conducting clinical programs consistent with applicable regulations, guidelines, and policies. Interprets and executes on policies and procedures appropriate to clinical programs under his/her management. Recommends modifications to policies and procedures to larger clinical organization as necessary
Accomplishes results through experienced clinical research employees who exercise significant latitude and independence in their assignments
Provides ongoing training, direction and guidance on all clinical programs under their supervision
Conduct quarterly performance reviews and continuous employee development
Provide leadership and program representation with internal partners and external customers
Supervise training of study personnel including internal staff and external study sites (e.g. Principal Investigators, Study Site Support Staff, etc.)
Functions as an advisor to the Clinical Department Leadership regarding study strategy, projects, individual tasks and overall study operations
Ensures projects/programs are completed on schedule and within budget. Will drive highest quality program execution. Continually assess best practices and implement continuous improvement across studies as well as provide input to global department program execution
Participate on key functional workgroups to drive clinical wide or cross-departmental initiatives
Provide significant input and oversight to clinical program budgets
Ensures appropriate resources are maintained to effectively conduct clinical programs
Gives direction to staff on program priorities for various projects assigned to their area
Proactively engages senior clinical management in program risk discussions and provides well thought out solutions to issues
Identifies opportunities to strengthen clinical program quality and efficiency by assessing resource needs and capacities to ensure business objectives are met

Clinical Research Manager Resume Examples & Samples

Oversees the direction, planning, execution and interpretation of clinical research projects consistent with all applicable regulations, guidelines and policies
Accomplishes results through managing Senior Clinical Research Associates
Provides leadership in areas of technical mentoring and clinical trial planning
Insure adequate training for employees; develops employees and evaluates their performance; contributes input to the hire, termination and promotion of employees
Insures projects are completed on schedule and within budget
Able to refer to Standard Operating Procedures (SOPs) and Department Operating Procedures (DOPs) for guidance on everyday study tasks
Develops clinical plans, guidelines and strategies in consultation with clinical team, cross-functional project team, and investigators
Interfaces with regulatory agencies and/or payers including pre-IDE meetings w/FDA and prepares and conducts presentations to FDA panel reviewers re: requirements and results of study
Facilitates or conducts meetings in area of expertise with internal clients and physician customers
Reviews, approves and implements CAPA findings and Audit Report with Quality Department
Authors/co-authors results of studies in the medical literature and/or presents at scientific meetings
Assists in preparation and approves Clinical Reports, PMA submission Package
Provides input and support for planning post-clinical educational activities and market launch of products
Regularly communicates with Senior Management on resource requirements and staff performance
May be assigned as a clinical team member of a project core team
Resolves complex issues with input from team members and cross functional teams
Frequent interactions with peers, clients, vendors on significant matters
Interfaces with representatives from key functional groups to drive clinical wide or cross departmental initiatives
Represents organization as a prime internal and external contact on specific projects
Drives completion of projects and departmental initiatives and processes
Provide input and support for post-clinical activities and market launch of products
May support global activity
Participate in training to enhance knowledge base and may attend relevant scientific and or medical meetings
Minimum 8 years experience directly supporting clinical research
Management experience with the ability to delegate study workloads to best meet departmental goals
Cost-center/budget management experience
International clinical and/or regulatory experience preferred
Extensive knowledge of GCP and regulatory compliance guidelines and regulations for clinical trials
Advanced written, oral and interpersonal communication skills, including proficient knowledge of medical and regulatory terminology
Intermediate knowledge of word processing, spreadsheet, database and graphics presentation applications, and electronic meeting/calendar coordination
Experience leading complex projects and project teams
Experience in resource and expense management
Ability to drive process excellence and compliance with product/service quality standards
Demonstrated ability to identify and adapt to shifting priorities and competing demands

Clinical Research Manager Resume Examples & Samples

Supervise and provide oversight and guidance as needed to research staff; Supervise activities of subordinates as assigned
Strong organizational skills and significant attention to detail for data entry
Self-motivated, willing and able to take initiative
Ability to work both independently and with a team to resolve issues with a positive outcome

Clinical Research Manager Resume Examples & Samples

Provides leadership in developing study-related documents (e.g., budgets, data collection tools, investigator files and informed consent documents)
Reviews invoices from investigative sites, study vendors, and institutional review boards (IRBs) he/she is assigned to
Participates in negotiating clinical study agreements and will review and approve monitoring reports and invoices
Participates in the analysis, summary and reporting of clinical data
Will task manage Clinical Research Coordinators that are assigned to their studies (the CRM will not have any direct reports) or act as their own Clinical Research Coordinator on smaller trials assigned to
Maintains good relations with investigators and sponsors, including physicians, medical research staff and outside consultants
Serves as liaison between investigative sites and the clinical research organization (CRO), if appropriate
Ensures appropriate resources are available for assigned studies and resolves conflicts and issues
Able to perform monitoring visits (SQVs, SIVs, IMVs, COVs)
As needed, the CRM will identify and work with outside vendors to coordinate acquisition of materials and equipment needed for clinical studies/trials
Acts as the main line of communication between the Sponsor and the investigator and maintains contact with internal cross-functional departments
Maintains good relationships with investigators and their staffs, including physicians, medical research staff, and outside consultants
Performs Research coordination, planning and logistics, including oversight of budget and timelines
Responsible for the safety and proper conduct throughout the trial
Verifies that the investigator follows the approved protocol and all GCP guidelines
Verifies that source data/documents and other trial records are accurate, complete, and maintained
Ensures adverse events, concomitant medications, and intercurrent illnesses are reported on appropriate CRFs in accordance with the protocol
Ensures all CRFs are reviewed in a timely fashion and submitted to the data management group
Communicates deviations from the protocol, SOPs, GCPs, and the applicable regulatory requirements to the investigator
Develops study-related documents (e.g., case report forms, investigator files and informed consent documents)
Reviews invoices from investigative sites, study vendors, and institutional review board (IRBs)
Participates in clinical study agreement negotiations and reviewing and approving monitoring reports on assigned studies
Helps to review clinical study reports
Resolves research conflicts and issues

Clinical Research Manager Resume Examples & Samples

Bachelor’s degree or higher in a biomedical-related degree or related scientific field, including nursing qualifications; or a bachelors degree and 5 years of clinical study/trial experience including experience as a Clinical Research Associate (monitor)
Medical device experience is strongly preferred
Has knowledge of ICH-GCP requirements and a strong interest in clinical research

Clinical Research Manager Resume Examples & Samples

Support the local/regional planning and execution of Celgene-sponsored clinical trials (phases I-IV)
Have a comprehensive overview of all Celgene sponsored clinical study activities in the country / region
Support the feasibility process for clinical programs and studies in collaboration with Clinical Operations and CRO partners, as appropriate
Proactively collaborate with CROs, and Study Teams for the execution of clinical trials
Coordinate, plan, attend and participate/present at local investigator meetings as appropriate
Collaborate with local Medical Affairs to ensure clinical support and regional activities are in alignment with corporate objectives, as appropriate
Keep informed on relevant local regulations and law and communicate to applicable personnel, as appropriate
Scientific / healthcare related degree, preferred
Extensive experience in the (international) pharmaceutical / medical field with solid clinical trial management / monitoring experience, mandatory
Any relevant therapeutic area experience will be considered. Haemartology / Oncology experience is desirable
Line-management experience desirable
Excellent written and verbal communication and interpersonal skills. Must be able to relate effectively to people at all levels of the organization
Working knowledge of SOPs/regulations relevant to clinical research
Computer literate; familiarity with Microsoft Office programs, in particular, Word and Excel

Clinical Research Manager Resume Examples & Samples

Line management of Clinical Research Associates (CRAs)
Recruitment, initial and continued training and development of CRAs
Oversight and Management of CRAs to ensure CRAs are meeting expectations of core monitoring responsibilities
Tracking and management of CRA resourcing/allocation of assignment; and
Manage turnover and retention of CRAs to meet company objectives
Bachelor’s degree with 4-6 years pharmaceutical industry experience (clinical monitoring or study management), including 3 years as a CRA, and 1-2 years as a CRA Manager preferred
Advanced knowledge of Good Clinical Practice
Strong leadership, mentoring, and motivational skills
Proficient knowledge of Microsoft® Office software; and
Occasional travel for evaluation of CRAs (approximately 10%); and
This position is office based in Cincinnati, OH

Clinical Research Manager Resume Examples & Samples

Execute and oversee clinical trial country submissions and approvals for assigned protocols
Develop materials including local language Informed Consents and translations
Work in partnership with IRB/IEC and Regulatory Authority on submission and approval-related interactions for assigned protocols
Manage country deliverables, timelines and results for assigned protocols to meet country commitments
Responsible for quality and compliance in assigned protocols in the country
Contribute to the development of local SOPs, may oversee contract workers (CTCs) and local vendors as applicable
Collaborate internally with GCTO country operations (CRM, CTC,CRA), CQM, Finance, Medical Affairs, Regulatory Affairs, PV, Business Compliance, Legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones
Responsible for clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management

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