Clinical Affairs Resume Samples

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I Koelpin

Izabella

Koelpin

4576 Adelbert Islands

Chicago

+1 (555) 707 2149

4576 Adelbert Islands

Chicago

Phone

p +1 (555) 707 2149

Experience Experience

San Francisco, CA

Clinical Affairs Coordinator

San Francisco, CA

Gutmann-Robel

San Francisco, CA

Clinical Affairs Coordinator

Work with internal R&D, RA, QA, and Marketing teams to design and manage clinical trials to support the company’s roadmap and strategy
Communicate regularly with Investigators and coordinators at clinical sites, manage site relationships
Assist with all operational responsibilities of all ongoing clinical studies
Site Initiation, training, monitoring, and site close out visits for external studies (includes local travel)
Review study documentation including protocols, informed consent forms, source documentation, case report forms, and other clinical forms
Trial Master File creation, organization, and filing
Clinical reports (including but not limited to Adverse Events, Protocol deviations, and endpoint analysis) to support 510K submissions

Boston, MA

Clinical Affairs Manager

Boston, MA

Crona, Kshlerin and Kassulke

Boston, MA

Clinical Affairs Manager

Develop and execute portfolio clinical strategies for both product development and life cycle management, in support of the Category business objectives
Assign objectives and monitor quality of work; assure management and employees conform to organizational policies and procedures and government regulations
Creates, manages and oversees the maintenance of all trial master files, at company and at investigational sites
Knowledge of relationship building with external partners and cross-functional internal teams to execute clinical development programs
Supports and establishes procedures and work instructions for key clinical research activities to assure compliance and efficient study conduct
Develop strong relationships for Intuitive Surgical with leading KOLs and with internal colleagues
Effectively oversees, supervises, directs, delegates, assists, and advises Clinical Research Associates monitoring clinical studies

present

Chicago, IL

Clinical Affairs Specialist

Chicago, IL

Yundt-Brakus

present

Chicago, IL

Clinical Affairs Specialist

present

Work cross-functionally with Regulatory Affairs and Quality Management, as workload permits, to support efforts in these areas
Attainment of all performance indicators as discussed with the line manager
Developing relationships with key leaders of the dental community
Work with QA, RA and R&D to insure compliance with protocols & evaluations
Keep in contact with clinical participants, receive feedback & photos, summarize information received and provide to the PM and/or project team
Prepare evaluation summary/progress reports necessary for DHF (PM provides input on conclusion and recommendations for next step in project)
Attend & participate in company sponsored events (Forum, NSM, seminars) and AAO and perform other duties as assigned

Education Education

Bachelor’s Degree in Business

Colorado State University

Bachelor’s Degree in Business

Skills Skills

Ability to learn fast and develop yourself
Dental or Health Industry background
Structured way of working
Consumer & Customer oriented mindset
Team player attitude
Valid driving license
Fluent Hungarian

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15 Clinical Affairs resume templates

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Director of Clinical Affairs Resume Examples & Samples

An advanced degree in a clinical field (eg, RN, PharmD) or non-clinical degree (PhD) with 5-10 years of relevant experience
Understanding of marketing and educational objectives of the pharmaceutical industry
Strong computer skills (Word, Excel, PowerPoint, Outlook), and knowledge of AMA style helpful
Exceptional written and verbal communication skills
Proven leadership ability
Experience in grant preparation and/or medical education
Managed care experience and/or pharmacy practice/administration experience

Director of Clinical Affairs Resume Examples & Samples

Advanced Degree in a Clinical field (eg, RN, PharmD) or non-clinical degree (PhD)
Experience in grant preparation and/or medical education will be beneficial
Microsoft Office/suite proficient Word, Excel, PowerPoint, Outlook, etc.)
Managed Care and/or Pharmacy Practice / Administration experience
Knowledge of AMA style

Associate Chair of Clinical Affairs & Operations Resume Examples & Samples

Leading the design, implementation and iteration of value-based clinical care models in key disease areas in pediatrics
Managing relationships with community physicians and groups in Austin, hospital partners, and public and private payers, with the goal of aligning operations around value across all players in the clinical ecosystem
Holding faculty accountable to the highest standards of clinical and operational practice
Overseeing various clinical practice models for faculty and affiliated physicians in the community
Developing metrics and performance evaluation processes for faculty members’ clinical contribution
Collaborating with other schools at the University of Texas at Austin and across the University of Texas system
Assessing new technologies and techniques in terms of their contribution to improving care and value in clinical care
Collaborating with the Associate Chair of Pediatrics for Education and other education leaders to ensure cohesive, mutually reinforcing initiatives
Representing the Department in key clinical decision-making bodies within the Dell Medical School and its partners
Collaborating with the Associate Chairs of Clinical Affairs and Operations in other Dell Medical School Departments on cross-cutting initiatives
Medical degree from an accredited medical school
Currently active board certification in pediatrics (may be from any pediatric medical field)
Eligible for appointment to the medical staff at Seton Healthcare
Eligible for appointment to the faculty as an associate or full professor
Substantial record of leadership and achievement in academic medicine
Experience with value-based care delivery and integrated practice models
Experience with business drivers of health care
Prefer advanced degree (e.g. MBA, MHA or similar training)

Director Global Clinical Affairs Resume Examples & Samples

Ensures projects are resourced appropriately and that clinical associates are qualified and trained
Leverages knowledge and experience to ensure that the development of clinical strategies and objectives for sponsored clinical programs achieve goals as directed by business management
Ensures timely completion of clinical trials within established budgets, timelines and quality metrics with a focus on continuous process improvement
Represents the operating company as a respected clinical trials expert including primary participation in industry consortia and regulatory agency meetings
Accountable for costs, methods and associates as defined by company policies and procedures. Cultivates a positive work environment that reflects company values, embraces collaboration across functions and businesses, and promotes associate development
Maintain and/or establish Standard Operating Procedures (SOPs) and a measurable process to build knowledge and ensure compliance with all applicable company policies, procedures and regulatory standards
Maintain strong, collaborative relationships with other functions and other operating companies in meeting business goals at the operating company and platform level
Maintain strong professional relationships with clinical investigators/coordinators, clinical and scientific advisory boards, and external contract research organization firms (as required)
Oversee the process for the timely and high quality preparation of assigned clinical deliverables including internal progress reports (metrics, bowlers, action plans), external reports to support regulatory submissions to the global regulatory agencies and clinical evidence intended for external audiences (e.g. abstracts, presentations, whitepapers, publications)
Oversee the process for effective collaboration with external entities (investigative sites, consultants, CROs, other suppliers, regulatory agencies, etc)
Maintain knowledge about key trends that affect the operating company and develop strategies that iteratively benchmark clinical function processes against industry best practice
Oversee the process where the clinical function participates in the review of documents such as publications, clinical reports, research proposals, and procedures/templates/guidances
Responsible for talent management of the function including workforce planning to ensure knowledge transfer through systems/processes to retain know-how, building such into programs for development planning of functional capability and onboarding of new personnel
20+ years equivalent job related experience in Clinical Research
Directly related experience in Clinical Program planning and execution, including an understanding of clinical strategy, the clinical laboratory, assay/instrument principles involving in vitro diagnostic product design and usage, and the scientific, statistical, regulatory and compliance requirements of clinical research
Demonstrated strong leadership competencies & skills in leading a global team of professionals
Experience managing large or complex clinical studies
Demonstrated ability to achieve goals through interaction with individuals not under their direct control
5-10 years management experience
5-7 years Laboratory (hospital, research, industrial), Quality Assurance or Diagnostic Customer Contact
Excellent oral and written communication skills,
High proficiency with desktop computer office software (MS Office, particularly Word and Excel)
Experience with pharmaceutical clinical research is desirable
Medical Technology MT(ASCP) or equivalent, or certification as a clinical research associate (CCRA), regulatory affairs professional (RAC) or clinical research coordinator (CCRC) is desirable

Development Team Leader, Clinical Affairs Resume Examples & Samples

Creating and executing a clear, integrated clinical development strategy for immunotherapy that will ultimately lead to regulatory approvals
Identifying, developing and implementing immuno-oncology asset and immuno-oncology combination regimens that have a strong mechanistic rationale, the potential to substantially improve upon the current standard of care, and support an aggressive clinical development plan
Leading collaborations with world experts (including other companies where appropriate) in the field of immuno-oncology to ensure optimization of the immunotherapy strategy and pipeline
Responsible for coordinating a cross functional Team(s) comprised of colleagues from Clinical Development, Medical Affairs, Translational Oncology, Statistics, Clinical Pharmacology, Regulatory, Safety, Project Management, Operations, Commercial Development, and Finance and other functions as determined by the needs of the team
Coordinate with the Translational Oncology Lead on the Asset Team in the thoughtful integration of biomarker and companion diagnostic studies into the clinical development strategy for each asset
Ensures that the project is managed appropriately per budget
Accountable for ensuring that the necessary resources are applied to the project team to support its success
Promotes a culture of innovation within the cross-functional team(s) in order to bring forward creative development plans that maximize the potential of each asset
May act as point of contact and project representative to governance and other decision-making bodies, including information dissemination and the resolution of critical project issues
Leverages line expertise to achieve the team goals
Able to engage with Business Development and contribute to efforts to optimize pre and post-PoC immuno oncology portfolio though in-licensing, out-licensing, co-sponsorship, and other collaborative efforts
Creates a motivated, committed and engaged project team Finish
Models and expects effective team behavior to achieve the project goals
Manages key interdivisional interfaces on project issues including but not limited to research, regulatory affairs, development, commercial, medical affairs, manufacturing and operations
MD Training Preferred: Proven ability to function effectively across a complex matrix organization with multiple stakeholders and constituents Minimum of 5 years of relevant experience in the pharmaceutical, academic and/or medical research environments having successfully executed a major component of a development program
Significant Phase 1-3 clinical research experience with strong understanding of the elements of drug development programs and experience in their design and execution
An organized, independent, self-motivated individual with exceptional presentation, written, and oral communication skills Able to tailor presentations to the knowledge level of the audience to suit their needs and maximize understanding of the topic

Clinical Affairs Specialist Resume Examples & Samples

University degree (PhD or MD required) in pharmaceutical, medical or other relevant biological science
A minimum of 3-5 years of experience of clinical studies for diagnostic, medical device or pharmaceutical products, including authoring protocols and reports
A solid knowledge of study design, biostatistics and Good Clinical Practice
Knowledge of oncology and/or pathology is preferred
High work capacity may be required at certain times in high priority projects
Experience from working with external international partners
Advanced communication skills, both written and spoken
Regulatory knowledge on medical device filings preferred but not required
Knowledge of CAP/CLIA guidelines preferred

Clinical Affairs Administrative Assistance Resume Examples & Samples

Support the VP of Clinical Affairs and other department managers with any administrative needs such as, but not limited to
Scheduling needs, routing trade journals, preparation of department and cross-company communications, telephonic and electronic communication support
Event planning support (to include logistics as well as presentation support and physical set-up responsibilities)

Global Clinical Affairs Senior Manager Resume Examples & Samples

Helps develop a framework for prioritizing strategic CA customer engagement activities
Helps develop and maintain a deep understanding of our global RCO CA needs to achieve business objectives
Manage the successful implementation of operational, process and new and improved programs and projects on time, within budget and within scope
Works with global, multi-location based, CA team members to align them with key initiatives
Works with Market Development Managers, Platform teams and other key stakeholders to successfully connect and execute CA support initiatives at the SBU and RCO level
Assists in developing project work scope and objectives, involving all relevant stakeholders and ensuring project feasibility
Applies best practices and the team’s talents to add value to the business, through successfully managing the completion and execution of projects and driving learning and improvements
Manages the collective relationsips between and among the stakeholders and team members, instilling confidence with the organization through consistent results
Oversees all management aspects of projects. Sets deadlines, assigns responsibilities, monitors progress
Manages changes to project scope, project schedule and project costs using appropriate verification techniques
Performs risk management to minimize project risks. Create and maintain project documentation
Prepares reports for upper management regarding status of projects
Frequent international travel to attend quarterly PAM meetings and interface with Switzerland-based staff
5+ years of business management experience
Cross Functional Leader/Project Management experience with medical device work experience
Understands the significant role of Clinical Affairs to facilitate adoption and use of a company’s medical device products and solutions to increase clinicians competency, effectiveness and efficiency
Change Management Leadership experience
Ability to manage people and projects
Effective presentation and interpersonal skills
Strong analytical/problem solving skills
Meeting and discussion facilitation skills
Decision making skills

Head of Clinical Affairs Resume Examples & Samples

Prepare budgets and manage the clinical operations program within established budget and timelines by ensuring development of accurate study budgets; contract development and execution; and approving payments and tracking of study expenditure
Direct the design; planning; development and monitoring of all clinical studies to ensure fulfillment of requirements for regulatory submissions
Coordinate functional areas involved in clinical operations to solve problems; assure project progress and timely completion of project goals
Direct Clinical Research Managers to ensure that clinical studies that meet user needs and regulatory requirements are conducted
Manage clinical operations by developing; mentoring; and effectively delegating
Effectively communicate; through the planning and execution of meetings and presentations; project goals; milestones; and updates; to senior management and other functional areas; and regulatory authorities
Develop and implement training programs to ensure compliance with relevant FDA and international regulations and ensure adherence to ICH/GCP guidelines
Monitor training effectiveness by assessing trends in audit observations and drive continuous improvement initiatives by developing new training activities; as appropriate
Negotiate contracts with investigators; vendors; and CROs
Provide compliance guidance on the conduct of clinical research division-wide; for developing and overseeing a quality training program and for compliance in all audits of the Clinical Research organization
Represent the Division's clinical research programs at cross-functional meetings; FDA meetings; FDA Advisory Committee meetings and in discussions with senior management and trade meetings
Accountable for achievement of performance and financial goals for area of responsibility. Aligns goals with long-term business needs of the organization. Uses resources effectively; reviews and monitors budget
Responsible for making timely decisions that reflect a consideration of the facts and data at hand and are in alignment with the overall business organization’s goals
Responsible for building relationships throughout the business organization and motivating the Clinical Research team. Must be skilled in relationship building and matrix management; demonstrating superior leadership and coaching skills
Effectively writes; presents and communicates information to internal and external clients; including business organization management
Must have effective negotiation skills. Accountable for interactions with FDA or other regulatory agencies regarding clinical research issues
Responsible for continuous improvement initiatives; leveraging new technology consistent with regulatory and compliance strategies; and assuring appropriate training and education programs are in place. Tracks appropriate metrics to ensure the effectivity of these programs
Maintains; promotes; and models ethical and organizational principles by adherence to the Abbott Code of Business Conduct

Clinical Affairs Manager Resume Examples & Samples

Develop and execute portfolio clinical strategies for both product development and life cycle management, in support of the Category business objectives
Support the evaluation and dissemination of clinical trial results: Contribution to statistical analysis plans; Review of clinical trial reports; Publication in peer-reviewed journals and scientific conferences
Develop clinical development plans driven by intended use (claims) and value propositions. Ensure their integration into Evidence Development Plans (EDPs), together with Epidemiology, Regulatory and Market Access
Ensure that all procedures are fulfilling legal and regulatory requirements. Organize management of serious adverse events
Serve as senior clinical expert to Regulatory Agencies, submissions and reviews, and to Payers decision making committees
Be the Company interface to the pediatric clinical development and medical community, including experts, practitioners and other stakeholders
In-depth knowledge of pediatric medicine to support NHSc vision and identification of opportunities
M.D. certified in Pediatrics with minimum of 10 years of experience in Clinical Development (pharma, biotech, diagnostics, medtech, nutrition)
Experience with design and management of clinical trials
Knowledge of relationship building with external partners and cross-functional internal teams to execute clinical development programs
Expertise in medical writing and verbal communication (protocols, clinical reports, regulatory submission documents, peer-reviewed publications, scientific meetings)

Clinical Affairs Coordinator Resume Examples & Samples

Coordinate the tracking of Essential Documents and key operational metrics for assigned studies
Perform Quality Control (QC) reviews of study documents to ensure that they are complete, accurate, and verifiable, and ensure that documents do not contain any PHI (Protected Health Information) in compliance with HIPAA requirements
Load and maintain study documents in Bard’s eTMF (electronic Trial Master File)
Interact with Investigational Sites to obtain study documents and related information
Update and maintain Bard’s Clinical Trial Management System (CTMS) for assigned studies to ensure accurate tracking of study contacts, vendor contacts and expiring study documents
Coordinate and participate in periodic review/audit of Trial Master Files to ensure that essential study documents remain complete, accurate, and verifiable
Assist in the development of study materials and tools to assist investigative sites during the clinical trial. Examples include regulatory and source document binders, template forms for Screen/Enrollment logs, Delegation logs, Device Accountability logs and training materials
Update and maintain project related systems, databases, tracking tools, timelines, and project plans (e.g., clinicaltrials.gov; SharePoint, etc.)
Under the direction of the study manager, coordinate investigational device inventory and accountability. This may include ordering devices from vendors for shipment to investigative sites, ensuring receipt at the site and tracking and accounting for all study devices at the end of the study
Coordinate the reporting and follow-up of reportable adverse events to Bard’s field assurance team
Prepare and distribute letters, memos, meeting minutes, and clinical administrative documents
Coordinate the receipt and processing of invoices, purchase orders, and purchasing requisitions, and track site/vendor payments
Coordinate project team meetings as needed (e.g., schedule rooms, coordinate logistics, prepare agendas, prepare/distribute minutes, etc.)
Strong organizational skills and a keen attention to detail
The ability to interpret and analyze a broad range of technical documentation
The ability to work independently at times with minimal supervision
Strong oral and written communication skills with an ability to proofread technical documentation for correct grammar, syntax, and spelling
Proven ability to prioritize multiple tasks in a fast-paced business environment
Proven ability to plan work and complete assignments on time
The ability to maintain confidentiality about information received in the course of duties
Strong computer skills with experience in Microsoft Outlook, Word, Excel, Access, Project and PowerPoint, and the ability to quickly learn and navigate Bard’s internal network systems (e.g., CTMS, SharePoint, etc.)
Knowledge of GCP-ICH and International regulatory requirements governing medical device research and development
Prior experience coordinating industry sponsored clinical studies

Reg Clinical Affairs Spec Resume Examples & Samples

Develops and executes regulatory strategy for assigned projects and interacts with regulatory authorities
Ensures compliance to US FDA Quality System Regulations and internal Quality System
Reviews and approves product labeling and advertising/promotional material
Participates in audits and inspections by regulatory authorities and certification/accreditation bodies
Experience with U.S. FDA 510k and/or PMA submissions and interaction with FDA reviewers preferred
Knowledge and experience with global registrations and development of medical devices a plus
Strong interpersonal, communication and organizational skills required
Must possess a high level of critical and strategic thinking skills and be a detail oriented team player
Must be able to set priorities as well as adapt to changing priorities
LI-LRP

Clinical Affairs Operations Manager Resume Examples & Samples

Oversee the execution and management of clinical studies, contracts, resources, and budgets
Oversee the activities of Clinical Operations personnel
Oversee clinical studies for compliance with protocols, corporate and divisional procedures, applicable regulations, and Good Clinical Practice guidelines
Plan and coordinate project resources and timelines
Participate in and leads multi-disciplinary project teams (including consultants and vendors) to coordinate all aspects of clinical study execution including site identification and start-up, clinical product availability, Trial Master File maintenance, routine monitoring, and study close-out.
Prepare and review documentation related to clinical trials including but not limited to case report forms (CRFs), Study Operation Plan, Monitoring Plan, CRF Completion Guidelines
When required, support field activities (e.g., monitoring, auditing) to ensure on-time performance of key activities
Oversite and management of external vendors and consultants as required
BS in health science field with commensurate training and experience
≥7 years of clinical study experience and/or a combination of ≥7 years of experience in commensurate clinical study and industry roles
Prior experience managing a team is preferred

Clinical Affairs Coordinator Resume Examples & Samples

Assist in the establishment and maintenance of all project documentation including clinical study files, records and reports according to the scope of work and SOPs. This includes telephone and email contact with physicians and clinical staff to obtain clinical study updates
Assist with periodic review/audit of files for accuracy and completeness
Coordinate and track information, communications, documents, and materials and supplies (including study devices) for assigned projects
Support the updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information
Prepare and distribute status tracking and project finance reports. Assist the Program Manager(s) with budget allocation and approval of invoices
Coordinate the preparation and approval of presentation materials for meetings (internal/external) and project summary data
Track study enrollment via Electronic Data Capture systems and any other study enrollment tracking tools (e.g., Clinical Trial Management Systems)
Receive invoices, pay study sites and track site payments. Generate invoices based on enrollment, CRA input, and the Clinical Trial Agreement
Support the coordination of project team and/or customer meetings including logistics and materials required
Prepare letters, memos and clinical administrative documents. Maintain confidential files involving product and clinical information
Special projects as assigned
Minimum two years of experience in a rapidly changing administrative environment dealing with changing priorities and timelines
Excellent interpersonal, problem solving and communication skills
Excellent follow-through capability
Self-motivated, attention to detail and organizational skills
Experience managing budgets and financial outputs
Experience with various computer systems / applications and clinical trial management systems an willingness to learn new systems / databases
Medical device experience preferred either within a regulatory or clinical setting

Clinical Affairs Specialist Resume Examples & Samples

Identify and evaluate potential evaluators and establish strong relationships with clinical evaluation sites and staff
Manage all user experience/design validation interactions (including conduct site monitoring as needed, training, enrollment tracking, evaluation material and clinical supply requests) and ensure appropriate and timely communications are maintained in order to keep evaluations on-track
Assist with the design and implementation of strategies, plans, and practices for design validations
Develop and prepare key evaluation documents in conjunction with other team members (e.g. protocols, informed consents, amendments, monitoring plans, summary reports)
Organize and participate in evaluators' meetings
Develop, edit and route user experience/design validation protocols
Work with QA, RA and R&D to insure compliance with protocols & evaluations
Assemble clinical packages to be sent to participating clinicians including NDAs, protocols, feedback forms & product
Keep in contact with clinical participants, receive feedback & photos, summarize information received and provide to the PM and/or project team
Prepare evaluation summary/progress reports necessary for DHF (PM provides input on conclusion and recommendations for next step in project)
Attend all team meetings for projects that have or will have user experience/design validations as well as attend any other meetings that request attendance from someone in Clinical Affairs
Attend & participate in company sponsored events (Forum, NSM, seminars) and AAO and perform other duties as assigned
Up to 20% domestic and international travel may be required to meet and engage with clinicians, academic partners, events and conferences as needed
2+ years professional experience in a clinical affairs, scientific research or product development environment
Background in the dental, healthcare, pharmaceutical or biotech industry preferred
Outstanding communication skills (written and oral) and must be detail-oriented
Strong organizational skills and attention to details required. Efficient in time management and able to prioritize and plan workload is essential
Excellent keyboard skills, with experience using Microsoft Office (Word, Excel, Power Point) applications to prepare charts, tables, forms, reports, and presentations
Must be able to work both independently and as part of a team

Clinical Affairs Manager Resume Examples & Samples

Development of clinical evidence strategy to address regulatory and reimbursement gaps, or otherwise for the medical community as required
Develop strong relationships for Intuitive Surgical with leading KOLs and with internal colleagues
Consult with leading KOLs, individually or via advisory panels to develop specific clinical programs
Actively represent clinical affairs in Germany, Switzerland and Austria; internally and externally for reimbursement or other government agency meetings or conferences as required
Intuitive Surgical Sponsored Studies
Graduate qualification in Life Sciences, medicine or medical sciences, with a preference for PhD
Experience working in medical device industry in the clinical affairs/research function, with evidence of full project management responsibility, for at least 6-10 years. Surgical or interventional medical device experience, phase III to IV is preferred
Excellent communication and interpersonal skills with strong influencing abilities
Experience of managing physician initiated projects preferred and CRO’s or external consultants required
Preferred knowledge of German, Swiss and Austrian reimbursement process and conduct of clinical studies in this area
German and English language required, other languages advantage
Experience of publishing clinical research (own or in clinical industry capacity)
Strong numerical and literary analytic skills - ability to assess data and literature quickly
Comfortable in a hospital/surgical environment
Must be able to travel about 50% (mostly domestic)

Clinical Affairs Manager Resume Examples & Samples

Actively represent clinical affairs in France, UK & Benelux; internally and externally for reimbursement or other government agency meetings or conferences as required
Preferred knowledge of French, UK & Benelux reimbursement process and conduct of clinical studies in this area
French and English language required other languages advantage
Must be able to travel about 50% (mostly in France)

Director of Clinical Affairs Resume Examples & Samples

Manages clinical study and operational teams
Provides scientific, technological and medical knowledge and expertise for the clinical research aspects of the project and provides clinical expertise, with a strong working knowledge of regulatory affairs, to the development of the clinical strategy for projects
Provides medical and scientific input to the core documents for the project (e.g., product strategy documents, target product profile (TPP), protocols, submission, etc.)
Consults with internal/external stakeholders and internal/external key opinion leaders to validate the scientific and medical components of clinical strategies
Works closely with the clinical affairs team, and provides strategic direction to support timely and on budget development and execution of the clinical strategies
Develops and gains approval by Senior Management for study protocol outlines and study plans created by the clinical project team
Plays a primary role in identifying key opinion leader(s)/principle investigators for the program to ensure adequacy of the program’s scientific basis and obtain endorsement on the assumptions related to medical needs and clinical utility represented in the project development strategy
Provides medical and scientific interpretation of efficacy and safety data and to seek advice of other experts as required

Clinical Affairs Manager Resume Examples & Samples

Manages all study related issues for Zimmer Biomet clinical outcomes studies and prospective randomized, non-IDE clinical studies
Individual must be comfortable multitasking and managing many simultaneous requests for field support for studies
Demonstrated ability to impact and influence others within a team to take action; interacts effectively with various functional groups of the project team; contributes significantly towards the establishment of best practices; serves as a resource and mentor
Demonstrates problem-solving strategies developing alternative solutions and contingencies to address issues as they occur
Supports coaching and feedback and as appropriate, provides performance input to senior management
Independently identifies potential barriers to project completion and proactively implement effective strategies to avoid such barriers
Demonstrates ability to effectively communicate to all levels of the organization
Effectively oversees, supervises, directs, delegates, assists, and advises Clinical Research Associates monitoring clinical studies
Demonstrated expertise and strong understanding of the overall project goals, the indication (s) studied and the purpose of the planned studies in meeting the objectives of the project, assist in the development of the clinical plan
In conjunction with the senior members of the project team (product management, research, engineering and regulatory affairs) manages administrative aspects of a clinical project/study including, training, study initiation, trial maintenance, data monitoring, data reporting, and payments
Supervises and coordinates clinical monitors workload within a project, as required; Plans and initiates the steps involved in the clinical research process; in conjunction with the clinical project leader, manages all aspects of a project in accordance with established timelines, applicable project standards and standard operating procedures
Facilitates the IRB review and approval process where required for all new clinical outcomes and comparative investigative sites
Monitors the progress of the project and updates clinical project leader on an ongoing basis; assists in the resolution of identified issues and assists in the resolution of more complex issues presented by the clinical scientist and engages director as needed
Prepares, oversees, and reviews the preparation of clinical documents, e.g., Protocols, Investigator Brochure, Annual Report updates, Case Report Forms and Clinical Study Reports; participates in the preparation of integrated documents for all clinical outcomes studies
Assures GCP compliant documentation system that maintains patient confidentiality
Demonstrated expertise and strong understanding of the overall project goals, the indication(s) studied and the purpose of the planned studies in meeting the objectives of the project, assist in the development of the clinical plan
Requires a Bachelor’s degree in health, life sciences, or engineering; a minimum of 10 years of experience with IDE studies in medical devices with direct responsibility for submissions development and content, or an equivalent combination of education and experience
Previous direct clinical study design, FDA interaction and negotiation, and study launch experience
Minimum three years successful experience in an orthopedic clinical management role
Minimum of two years of experience in supervising and directing three to five CRA’s
Previous demonstrated experience in, and responsibility for study budget, enrollment, inventory and progress reporting

Senior Imaging Analyst, Clinical Affairs Resume Examples & Samples

Patient Screening Analyses: Performs CT reconstructions and echo analyses to assess patient suitability for clinical trials and compassionate use cases. Present findings to internal screening team and participate in screening team discussions. Present patient analyses on case review calls with our clinical partners
Site Education: Assist with ongoing education of physicians and clinical research coordinators regarding the screening process and patient suitability criteria. This can include answering questions via email and phone, as well as attending site initiation visits and physician training sessions
R&D Support: Provide CT, echo, X-ray, and fluoroscopic analysis in support of R&D activities. Perform CT segmentation and create models
5 years’ experience in one of the following is required

Senior VP of Clinical Affairs Resume Examples & Samples

Strategy development
Proven ability to work with a high level of integrity and to effectively challenge others and raise issues when important or potential safety issues pose risk
Strong technical and analytical skills to identify and solve problems
Self-motivated, assertive, and self-confident with the ability to act with urgency and passion
Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting in order to effectively manage a function
Excellent verbal and written communication skills for effectively interfacing with all levels of management and departments within the company
Ability to make thoughtful, integrated, timely and meaningful decisions and take corresponding actions
Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing relationships in order to strengthen decision-making
Willingness to encourage a spirit of innovative thinking to foster process improvements
Entrepreneurial and enjoys working in a fast-paced, small-company environment
Ability to work under pressure, meeting time sensitive deadlines, while maintaining a high level of confidentiality
Strong background in clinical practice, academia, or regulatory agency and understanding of competitive commercial landscape for hereditary cancer testing
Actively engaged in industry developments including professional meetings, scientific congresses, advisory boards, authorship in peer reviewed publications, abstracts, posters, and podium presentation at scientific and industry meetings

Executive Assistant, Clinical Affairs Resume Examples & Samples

Effectively and proactively manage the Vice President of Clinical Affairs calendar, appointments, and office filing/organization
Coordinate domestic & international travel, hotel accommodations and meeting schedules for Vice President and direct reports
Answer/screen calls and draft correspondence, manage meeting agendas, prepare expense reports and track
A High School diploma and a minimum of 6 years of directly related experience in executive administrative support
Strong ability to work in a fast-paced, dynamic environment
Ability to build and maintain strong relationships across the organization, with all levels of employees, as well as with external stakeholders to influence and achieve objectives
Advanced proficiency in MS Office Suite, including Word, Excel, Outlook and PowerPoint
Ability to manage complex calendars, meetings and travel arrangements to optimize time
Ability to manage internal and external confidential information with utmost discretion
Works autonomously within established procedures and practices
Understands implications of work and makes recommendations for solutions

Administrative Assistant, Clinical Affairs Resume Examples & Samples

Under direction of study manager, develop and maintain in-house master study files and site study files for multiple clinical research trials (in both paper and computerized files (clinical trial management system)
Responsible for managing the flow of regulatory and training documents from internal and external sources for record retention and maintains computerized tracking system of the documentation
Reviews documents for accuracy and completeness. Conducts periodic audits of documentation and participates in internal master file audits. Contacts team members as needed, to obtain updated /revised documents
Professionally interacts with both internal and external customers to obtain required documentation
Supports clinical team member’s requests for filing or document retrieval of study documents
Under the direction of the study manger or in-house CRA, collates new study materials, creates study binders, and arranges shipment of devices and study materials to clinical sites
Maintains study contact lists
Scans and uploads documents to the CTMS for remote access by team members and file the hardcopies of the documents in appropriate file folders
Places device shipment orders and maintains inventory tracking, processes returns
Works with team to identify and process required payments
Works with team to process contracts and other legal documents as required
A minimum of 2 years of experience in an administrative role
Must be proficient in Microsoft Office – Word, Excel, PowerPoint, Adobe Acrobat
Excellent organizational skills, and highly developed diplomatic and interpersonal skills
Must have demonstrated decision-making skills, as well as independent initiative with the ability to influence others
Proven ability to function well under pressure and balance day-to-day requirements with special projects required
Ability to work in a team environment is essential
Demonstrated ability to produce results and excellent communication, both verbal and written, are required
A bachelor’s degree in business, pharmaceutical science or a biological science is strongly preferred. A combination of related education and equivalent work experience may be substituted for a bachelor's degree
Medical device or pharmaceutical industry experience working with FDA regulated documentation is strongly preferred

Clinical Affairs Specialist Resume Examples & Samples

Participate in the evaluation of study proposals for consistency with company objectives, regulatory compliance requirements, and adequacy of study design
Develop and write protocols for company supported studies with input from technical, regulatory, quality assurance, and marketing personnel and, as appropriate, regulatory agencies
Initiate and monitor clinical research studies in compliance with all applicable regulations and company standard operating procedures
Critically analyze and evaluate clinical data presented in literature or generated as part of company sponsored studies
Establish and maintain professional relationships (in person, by phone and/or email) with clinical investigators, clinical sites and regulatory agency contacts as necessary to support clinical studies and regulatory submissions
Under direct supervision, compile clinical study data, compose clinical study reports and documents for regulatory communications including submissions (pre-IDE, 510(k), CLIA Waiver)
Actively monitor status of communications with clinical study sites
Maintain and manage clinical study activities in database systems, consistent with company timelines and objectives
Construct and audit clinical files
Up to 30% domestic and international travel time spent in support of clinical studies
Bachelor's degree (BA/BS) in chemistry, biology or other science (Master’s degree preferred) or equivalent combination of education and experience
Three to five years’ experience in clinical study research and/or in biotechnology or related industry preferred
Experience with application of GCP and interpretation of FDA and/or international regulations for clinical research desirable
Strong organizational, interpersonal and writing skills required
Excellent communication skills necessary to prepare effective documentation
Strong background in scientific analysis needed to assess current publications, to converse with clinical and regulatory contacts, and assist in the development of protocols that are consisted with current laboratory diagnostic standards

Senior Director of Clinical Affairs Resume Examples & Samples

A person who is excited by the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience challenging, often demanding situations
We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job
We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life billions for the billions of people Philips brand touches each year

Clinical Affairs Resume Examples & Samples

Strong business experience, preferably Sales
Dental or Health Industry background
Preferably college / university degree
Consumer & Customer oriented mindset
Structured way of working
Ability to learn fast and develop yourself
Team player attitude
Fluent Hungarian

Senior Specialist, Clinical Affairs Resume Examples & Samples

Researches and helps establish clinical and/or usability study objectives, strategy, scope, budget and schedule in support of assigned new product development and sustaining engineering projects
Coordinates clinical research activity on assigned product(s), including recruitment and selection, communication, training and monitoring of all staff (investigators, research staff, study participants)
Creates and reviews protocols for completeness and feasibility
Creates, Analyzes and reviews interim and final reports on clinical study data/information to obtain recommendations on project direction
Helps to manage the use of 3rd party Clinical Research Organizations (CRO’s) and other related contractors
Controls investigational device distribution and allocation
Interfaces with representatives from key function groups including User Experience, Patient Safety, Quality, Regulatory, Biostatisticians, Research & Development, Risk Management and Marketing
Reviews and tracks study schedules and objectives
Learns design controls, quality systems and risk analysis
RN, BSN or BS Biomedical Engineering or other related health care degree with focus on Nursing Health Services, Public Health, Informatics
Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials or research certification (Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP)
Minimum 2-4 years of clinical and/or clinical research experience
Skilled written, oral, and interpersonal communication skills including proficient knowledge of medical terminology
MS word, Excel, PowerPoint

Clinical Affairs Specialist Resume Examples & Samples

Support and establish clinical research strategy
Design, plan and implement the clinical research studies
Understand and ensure compliance with policies and procedures required for clinical validation within the Partners HealthCare system
Prepare Internal Review Board (IRB), data sharing committee, and other documentation as required by the clinical investigation and regulatory requirements
When appropriate, recruit and qualify clinical investigative sites
Analyze data acquired during the course of the clinical investigation, prepare reports and presentations based on clinical findings
Support product leaders by interfacing with end users to elicit and build empathy with voice of customer, building intimate knowledge of user workflow, pain points, and product needs in order to drive product usability and acceptance
Use the Partners HealthCare values to govern decisions, actions and behaviors. These values guide how we get our work done: Patients, Affordability, Accountability & Service Commitment, Decisiveness, Innovation & Thoughtful Risk; and how we treat each other: Diversity & Inclusion, Integrity & Respect, Learning, Continuous Improvement & Personal Growth, Teamwork & Collaboration
BA/BS (or higher level of education), ideally in a quantitative discipline, biological science, or technologist/nursing is required
5+ years experience in clinical trial planning, support, and coordination in medical devices or software is required
Demonstrable experience with and comprehension of the major considerations of clinical trial study design is required
Comfort with basic statistics and proficiency with Excel, PowerPoint and database software are required
Demonstrable presentation skills required (e.g., storyline and presentation development)
Experience in a startup environment, and/or exposure to the fields of data science and machine learning are strongly preferred
Ablility and willingness to obtain required hospital credentialing to gain appropriate access to required areas of the investigational site
Strong sense of urgency and proactiveness – ability to manage and drive work and agenda independently, and source inputs from manager and team as needed
Strong analytical, planning, organization and time management skills
High attention to detail and understanding of end-to-end processes
Demonstrated eagerness to move out of existing comfort zone and learn new skills
Excellent and succinct written and oral communication skills
Excellent interpersonal/team effectiveness skills
Ability to build consensus among cross-functional teams and influence decision making within senior-level audiences
Ability to effectively conduct meetings and lead and facilitate large working sessions with all levels of staff
Excellent interpersonal skills to effectively communicate with cross functional teams including staff at all levels of the organization including both technical and non-technical personnel
Proven track record of executing challenging analytic and problem solving projects to drive measurable business value
Ability to structure complex, ambiguous, and potentially challenging business issues for center leadership and to develop compelling, insightful recommendations
Ability to gather and analyze large amounts of information quickly and accurately, and synthesize findings into an actionable summary and clear next steps
Strong project management skills; knowledge of process and project planning best practices
Willingness and ability to juggle numerous projects simultaneously, and respond to changing priorities
Ability to function effectively and independently in a fast-paced environment, organize and prioritize work independently, and meet tight deadlines
Willingness and ability to handle confidential matters with utmost discretion
Ability to successfully collaborate with others of different skill sets, backgrounds an levels within and external to the organization

Clinical Affairs Liaison Resume Examples & Samples

Partner with U.S. team to develop strategic plans for the BSHS medical education and clinical research portfolio timed for key European societal meetings
Create engaging and varied learning programs that meet the needs of our healthcare professionals- ie: Virtual, Webex etc
Consult with faculty and internal team on educational program objectives, design and implementation
Supports regional Clinical Research programs including contracting and milestone administration
Oversees Scientific Advisory Boards and/or focus groups as needed
Manages all logistics to include KOL contracting, post program feedback and budgets
Attend appropriate scientific meetings, conduct routine literature searches and communicate key learnings to the CA team for further dissemination of meeting/publication results
Maintains monthly schedule of Medical Education programs and ensures survey/feedback is collected and summarized quarterly
Liaise with Sales for physician and allied health training programs (webinars, seminars, CME/CEU activities and workshops)
Develops and manages a budget
Responsible for all compliance with regards to Healthcare Professionals and country specific laws
Takes on other roles and responsibilities that may be required in support of Hologic’s or the department
Work collaboratively across multiple levels of the organization and lead influentially, must have exceptional judgment, integrity, and ethics
Flexible and able to work on multiple projects with aggressive timelines. Must be hard-working, energetic and passionate about making a difference with the highest integrity; committed to ethics and scientific standards
Understand and effectively communicate scientific and medical information to both internal and external customers. Excellent written and oral communication skills are imperative
Anticipate and adapt to change while maintaining the momentum of an overall strategic plan
Work independently, yet engage in collaborative decision making, to complete tasks in a timely fashion, and function in a rapid-paced environment
Establish strong relationships with peer groups, professional organizations, and other outside parties to further departmental and corporate objectives & goals
Experience in Breast and Skeletal Imaging is preferred

Clinical Affairs Intern Resume Examples & Samples

Currently enrolled in an accredited university towards a bachelor's degree
Have strong written and verbal skills, organizational skills
Basic computer knowledge including experience with Microsoft Office Suite (Word, Outlook, Excel, Powerpoint)
Ability to work in a diverse/fast paced environment

Field Clinical Affairs Analyst Resume Examples & Samples

Bachelor’s Degree in Operations or related field. 3-5 years of experience in /Operations or related field, sales operations or business analyst equivalent. Ability to create and deliver complex business solutions in today’s changing business environment. Comprehensive verbal and written communication, interpersonal and presentation skills. (NEW)
Requires highly developed experience sufficient to assume responsibilities of multi-tasking, prioritizing projects, meeting deadlines, forecasting milestones within a budget
Financial Modelling Expertise and strong analytical skills
Strong bias towards self-checking quality control to deliver robust, reliable data. Precision and accuracy while being able to work with some level of ambiguity and data assumptions is a must-have
Understand limitations of current systems and be comfortable to fill in with assumptions as appropriate
Identify and prioritize areas for process improvements

Senior Specialist, Clinical Affairs Resume Examples & Samples

Coordinates clinical research activity on assigned product(s), including selection, communication, training and monitoring of all staff (investigators, research staff, study participants)
Provides and reviews interim and final reports on clinical study data/information to obtain recommendations on project direction
Controls device distribution and allocation
Interfaces with representatives from key function groups including Patient Safety, Quality, Regulatory, Biostatisticians, Research & Development, Risk Management and Marketing
Travels up to 30%, including internationally
REQUIRED SKILLS, EDUCATION, AND EXPERIENCE
RN or RRT licensure preferred

Clinical Affairs Manager Resume Examples & Samples

Participate and manage the overall day-to-day operations of multiple clinical studies
Coordinates and prepares Clinical Investigational Plans and supporting clinical study materials
Develops and manages clinical study plans and budgets and is responsible for monitoring and achieving targets. Conducts routine and ad hoc meetings and written updates, with clinical affairs, cross-functional teams and company leadership to drive projects and share key information. Manages study budgets and accounting
Ensures effective and efficient study initiation through procedures and best practices in site qualification and development. Ensures timely trial progress including site management for effective subject recruitment and protocol compliance. Ensures clinical data integrity is maintained through appropriate oversight of staff, sites and monitoring practices through all phases of the studies
Manages medical monitoring processes, core-labs and other contracted study vendors. Liaises with study committees such as Steering and Data and Safety Monitoring Committees
Assist in preparation of Clinical Reports for regulatory submissions, including IDEs, PMAs, 510Ks, foreign filings and Clinical Reports for other data dissemination activities
Develop and maintain working relationships with CROs, contract clinical support staff, and site investigators and staff, including qualification, selection, budget and work-scope negotiations and oversight
Supports and establishes procedures and work instructions for key clinical research activities to assure compliance and efficient study conduct
Coordinates and prepares clinical study reports and summaries on clinical trial results for internal review by other departments and senior staff. When appropriate, supports the preparation manuscripts for publication of trial results in refereed journals
Creates, manages and oversees the maintenance of all trial master files, at company and at investigational sites
Recruit, lead, manage and develop assigned team to continually improve performance, evaluate strengths and developmental needs; provide appropriate feedback, coaching and mentoring to ensure high levels of performance within the reporting function
Provide day-to-day guidance and oversight of managers and employees; attract and select a top team, train, supervise, motivate, and develop managers and employees; oversees establishment of effective schedules and workflow; actively work to promote and recognize performance. Be prepared for and manage on-site or remote regulatory audits by company or regulatory agency representatives
Assign objectives and monitor quality of work; assure management and employees conform to organizational policies and procedures and government regulations
Keep up to date on overall activities of the team; develop employees; identify problem areas and take corrective actions when needed to address performance or disciplinary issues
Support company goals and objectives, policies and procedures, performance management programs, and applicable national and local regulations

Clinical Affairs Coordinator Resume Examples & Samples

Work with internal R&D, RA, QA, and Marketing teams to design and manage clinical trials to support the company’s roadmap and strategy
Assist with all operational responsibilities of all ongoing clinical studies
Review study documentation including protocols, informed consent forms, source documentation, case report forms, and other clinical forms
Site Initiation, training, monitoring, and site close out visits for external studies (includes local travel)
Monitoring follow up, documentation, and reports
Communicate regularly with Investigators and coordinators at clinical sites, manage site relationships
Ensure proper device and regulatory documentation prior to study start
Ensure compliance with study protocols, company SOPs, and all applicable federal regulations
Maintain clinical schedules and budgets
Drive recruitment of subjects for clinical studies
Scheduling, consenting, treatment, assessments, documentation, and monitoring for internal pilots
IRB submissions (e.g. protocols and amendments, informed consent forms, continuing reviews, study closures, etc.)
Database entry, data verification, query generation
Clinical reports (including but not limited to Adverse Events, Protocol deviations, and endpoint analysis) to support 510K submissions
Trial Master File creation, organization, and filing
Presentations of clinical results, lead clinical meetings
BS degree required
1-3 years’ experience in a clinical role in an FDA regulated industry required
Ability to work as an individual contributor as well as interact with cross-functional teams and outside organizations
Strong organizational and time-management skills required handle numerous projects in a fast-paced environment

Clinical Affairs Specialist Resume Examples & Samples

Independently manage clinical trials, which may include protocol, ICF and CRF development, investigational product / supply management, budget / contract negotiation and regulatory document collection / management
Independently monitor clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs, utilizing knowledge of the diagnostic area sufficient to perform source data verification and monitor study protocol conduct / compliance; occasional handling of biological samples may be required, based upon project need
Assist clinical sites with IRB submission / documentation, as needed
Utilize a working knowledge of GCP and SOPs to assure compliance with FDA regulations and applicable processes and procedures
Anticipate and identify problems / issues and implement resolutions or provide recommendations for corrective actions in relevant job areas
Work cross-functionally with Regulatory Affairs and Quality Management, as workload permits, to support efforts in these areas
BS/BA in life science discipline or equivalent combination of education and experience
Demonstration of 5-8 years of successful experience in related field and successful performance of responsibilities presented above
CCRA certification with ACRP or SoCRA
Experience in in vitro diagnostics and/or the medical device industry
Demonstration of strong writing skills in all job responsibilities (e.g. protocols, monitoring reports, correspondence, clinical trial reports, etc.)
Demonstration of effective oral communication skills with clinical sites, and internal / external personnel from various departments / levels
Ability and willingness to travel, domestic and international, depending upon project need, periodically up to 30-50% domestically; <10% internationally
MT/MLT or equivalent
Experience with clinical trials involving hemostasis and/or urinalysis analyzers
Experience with Pre-Subs and 510k submissions

Clinical Affairs Specialist Resume Examples & Samples

Support Philips CZ in selling Philips Oral Health Care products to dental professionals
Have a full understanding of science behind the product, usages and the market
Attend local, regional, and national trade shows as defined by territory needs
Support Philips CZ in building strong customer intimacy & building the brand
Drive point of Philips CZ sale presence and activity
A minimum of 2 years of experience in sales
Previous professional experience as a Sales Representative - Medical/Pharma/FMCG/ Retail will be considered as advantage
Work experience in an international environment will be considered as an advantage
University degree is a plus
Very good computer skills - MS Office
Business acumen, knowledge and understanding of local market
Excellent organization and coordination skills
Self-motivated, self-starter & comfortable with working independently
Driving license, category B
Availability to travel within the region
Fluent Slovak, good command of English
Genuine interest for well-being and a healthy lifestyle