Director, Clinical Research Resume Samples

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E Gislason

Enrico

Gislason

473 Ima Brook

New York

+1 (555) 354 8475

473 Ima Brook

New York

Phone

p +1 (555) 354 8475

Experience Experience

Detroit, MI

Director, Clinical Research

Detroit, MI

Rippin LLC

Detroit, MI

Director, Clinical Research

Directing and implementing Clinical research plans and programs according to established design principles. Directing the integration of the CDP and DDP
Participation in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds
Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; and
Leading the development of Clinical Protocols to meet CDP objectives
Planning clinical trials (design, operational plans, settings) based on these clinical development strategies
Developing of clinical development strategies for investigational or marketed Oncology drugs
Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications

San Francisco, CA

Associate Director, Clinical Research

San Francisco, CA

Bogan LLC

San Francisco, CA

Associate Director, Clinical Research

Assist Senior Director, Clinical on developing of clinical program for projects
Develop study specific training documents and investigator’s brochures
Participate in the development of implementation of clinical trial documents
Manage CRO’s and other vendors; monitoring and audit activities to ensure studies compliance with GCP/ICH guidelines
Conduct monitoring and co-monitoring activities
Maintain current knowledge of relevant regulations, including proposed and final rules
Lead all necessary activities including setting up, monitoring and reporting of bio studies

present

Los Angeles, CA

Director Clinical Research Operations

Los Angeles, CA

Smitham, Schumm and Schmidt

present

Los Angeles, CA

Director Clinical Research Operations

present

Provides direct leadership and management for PHC research operations team members
Continuously evaluates research program compliance, quality, and effectiveness, identifies, and develops opportunities for improvement that provide greater value for stakeholders
Leads process improvement and organizational change initiatives toward program optimization
Partners and collaborates with the PHC Compliance office to evaluate and address research compliance issues and risks
Encourages expanded participation from existing physician investigators through action oriented and expert support and helps to inspire and support new investigators in the sponsored research program
Organizes and structures PHC research administrative services to expand the capacity of the research program with a focus on increasing and diversifying sources of revenue and financial support
Directs an effective system of marketing and communication across PHC, the research community, and key stakeholders, to build and promote a positive image of PHC sponsored research

Education Education

Bachelor’s Degree in Relevant Life Science

Southern Illinois University Carbondale

Bachelor’s Degree in Relevant Life Science

Skills Skills

Ability to multi-task and manage several projects in parallel, paying attention to detail
Strong leadership skills (scientific and business) and proven ability to coordinate and lead local teams to high performance
Excellent oral and written English language skills
Strong project management skills
Good written and verbal communication skills
Knowledge of regulatory environment and guidelines (ICH, GCP and CFR)
Ability to resolve routine issues effectively and independently
Significant medical and scientific knowledge
Strong partnering and collaboration skills
Knowledge of Clinical Development Process

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15 Director, Clinical Research resume templates

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Director, Clinical Research Otc Pain Resume Examples & Samples

Lead the medical and clinical aspects of new product development strategies and drive strategy implementation
Demonstrate expertise in clinical study design, protocol development and implementation of clinical studies
Demonstrate leadership skills and ability to manage complex processes and initiatives
Have strong analytical and qualitative skills and ability to synthesize data, draw conclusion and implications, and translate into comprehensive strategies and recommendations
Assist with safety monitoring/reporting of all company-sponsored research activities
Help explore and evaluate new product ideas to assist in identifying new marketing opportunities
Act as principal clinical liaison with all domestic and international regulatory agencies and external opinion leaders
Requires a Medical Degree (MD, DO or equivalent)
PhD or PharmD may be considered with considerable pain related clinical research experience
A minimum of 5 years of clinical research and/or medical affairs related industry experience is required
An active license to practice medicine in the US or Canada is preferred
Clinical experience and subject matter expertise in pain management and/or OTC experience is required
Strong technical and business leadership skills are required
Prior global industry experience and/or emerging market experience is a plus
Ability to function in situations that can have a high degree of ambiguity
May require up to 10% annual travel (domestic and international)Clinical Research MD

Director, Clinical Research Operations Resume Examples & Samples

Perform long-range planning and the deployment of critical administrative resources toward positioning the University of Arizona’s College of Medicine – Phoenix units to provide comprehensive and efficient support for clinical research
Work closely with the HIPAA office and Human Subject Privacy Protection Program for policy interpretation, investigations and corrective action plans
Implementation of a comprehensive clinical research training, education and professional development program for faculty and staff including subject recruitment, team communication, CRF submission, adverse event reporting, Good Clinical Practice
Oversee clinical research within our research units including overall operations, scheduling and staffing and strategic decisions
Excellent communication skills and ability to work with a wide range of people at all levels of the organization
Ability to understand and interpret laws, regulations and policies related to the responsible conduct of research and good clinical practice
Experience and knowledge of institutional compliance and federal regulations regarding care and use of animals
Demonstrated computer skills using Word, Excel, Outlook and PowerPoint
Direct experience in a clinical research environment

Assoc Director, Clinical Research Resume Examples & Samples

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PhD or MD-PhD with at least 10 years experience in applying imaging to drug development
Extensive technical and clinical experience in quantitative clinical imaging technologies, in areas such as, but not limited to, MRI, molecular imaging, CT, and ultrasound
Understanding of technology cycles and the ability to identify novel technologies and develop plans for practical implementation in an industrial research setting
Thorough understanding of next generation imaging technologies and those most likely to deliver impact
Evidence of impact through identification and championing of new scientific initiatives
Evidence of ability to problem solve and influence in complex experimental designs
Evidence of scientific leadership role with responsibility for research project delivery
Strong inter-personal relationship skills with ability to work in diverse teams
Demonstrated ability to provide technical expertise in a multidisciplinary scientific environment
Strong and effective communication skill

Director, Clinical Research Resume Examples & Samples

Directing and implementing Clinical research plans and programs according to established design principles. Directing the integration of the CDP and DDP
Leading the development of Clinical Protocols to meet CDP objectives
Serving as a Study Director and driving the execution of studies from protocol concept to final report including interpretation of clinical data
Willing to serve as a Medical Monitor and possibly, Study Director for a study or clinical program; including review and monitoring study safety data
Interpreting study data and developing integrated summaries of safety and efficacy
Contributing clinical expertise to regulatory documents (e.g., briefing books, INDs, NDAs, etc.). May represent Clinical in discussions with Health Authorities
Acting as a coach and mentor to staff members across the NBG unit
Setting key deadlines and project milestones for projects within the function
MD required; Sub-specialty training in Neurology or Psychiatry
A minimum of 5 years in pharmaceutical clinical development with experience directing Neurology Phase II-III global multicenter studies
Strong interpersonal and leadership skills; demonstrated ability to build consensus and drive change in a matrix environment with cross functional teams
A thorough understanding of clinical research methodology including study design, protocol writing, and study report preparation
Comprehensive understanding of GCP of local regulatory requirements
Working knowledge of the IND/NDA/CTA/MAA processes acquired through direct industry experience
Working knowledge of currently available clinical technologies and assessment tools, and drug mechanisms of action
Previous participation in the selection of new compounds for clinical development and IND filing in neuroscience through technical evaluation of licensing and/or partnering opportunities
Solid understanding of the drug development process based on experience gained in the pharmaceutical or biotech industry
Excellent oral and written communication and presentation skills
Knowledge of the role of biomarkers and neuroimaging in evaluating pharmacodynamic effects preferred
Experience with pediatric and epilepsy studies is a plus
Annual travel required may be up to 10% (domestic and some international)

Director, Clinical Research Resume Examples & Samples

Directs and implements clinical research plans and programs according to established design principles
Directs the integration of the Clinical Development Plan (CDP) and the Drug Development Plan
Leads the development of Clinical Protocols to meet CDP objectives
Serves as Study Director and drives the execution of the study from protocol concept to final report including interpretation of clinical data
Serves as the Medical Monitor for a study or clinical program, reviews and monitors study safety data
Implements strategies to identify, monitor and resolve clinical/program trial issues
Serves as the clinical/medical team expert to provide direction to all project team functions, organizes Advisory Board meetings (e.g., agenda setting), and identifies and liaises with KOL regarding program strategy and scientific advice
Interprets study data and develops integrated summaries for safety and efficacy. Contributes clinical expertise and content to regulatory documents (e.g. briefing books, NDAs, etc.)
May represent Clinical team in discussions with Health Authorities
Sets key deadlines and project milestones within function
Makes appropriate budgetary allocations to targeted opportunities
Reviews 3rd party (contractors, consultants and vendors) work product an deliverables to approve payment of invoices and resolves issues
Leads by example to encourage others to prioritize personal and professional development
Complies with all applicable laws/regulations of each country in which we do business
Demonstrates high ethical behavior at all times, whether dealing with colleagues, vendors, patients, or physicians
Medical Degree
Board Certification or Eligibility in Oncology is preferred; will consider candidates with Oncology Clinical Development experience in lieu of Board Certification
Clinical trial experience in an academic or industry setting; demonstrated experience and involvement in clinical trial design or execution
Clinical trial experience in the setting of pharmaceutical industry with demonstrated experience and involvement in clinical trial design or execution is a plus
Clinical experience and academic track record in solid tumors or hematologic malignancies is preferred
Must be able to demonstrate the ability to influence others (both cross-functionally and within the function) in order to create a positive working environment
Innovative and inquisitive with a hands-on, practical approach to achieving deliverables
Must be a self-starter, self-motivated and must also be effective in influencing others
Must be able to provide guidance to Medical Monitors/ Clinical Scientists
Experience in writing trial synopsis, protocols, IB and study reports; Proficient with MS Office programs (PowerPoint, Excel & Word)

Director, Clinical Research Resume Examples & Samples

Directing and implementing clinical research plans and programs according to established design principles
Directing the integration of the CDP and DDP
Leading the development of the Clinical Protocols to meet CDP objectives
Serving as a Study Director and driving the execution of the study from protocol concept to final report including interpretation of clinical data
Serving as the Medical Monitor and Study Director for a study or clinical program to review and monitor study safety data
Implementing strategies to identify, monitor and resolve clinical program/trial issues
Serving as SME to provide direction to all project team functions, organizing Advisory Board meetings (e.g.) agenda setting, and identifying and liaising with KOLs regarding program strategy and scientific advice
Interpreting study data and developing the integrated summaries of safety and efficacy
Contributing clinical expertise and content to regulatory documents (e.g., briefing books, NDAs, etc
May represent Clinical in discussions with Health Authorities
3 - 5 years of clinical research in a pharmaceutical environment; will consider candidates with prior early or later phase experience
Study-specific experience in the areas of liver disease and blood disorders including Thrombocytopenia are highly preferred
In-depth knowledge of drug development principles and clinical trial execution
Experience conducting global clinical trials and basic knowledge of regulatory requirements is required
Prior experience communicating with and presenting to Regulatory Authorities on study/program design strategy and analysis of results as they relate to filings and clinical trials is preferred
Prior partnership experience in drug development is highly desirable
The ability to lead the complexities associated with co-development efforts and work cross functionally with a collaborative style that builds alliances and emphasizes Eisai Core Values (integrity, respect, professionalism, quality and teamwork) in a fast paced environment
Strong team leadership and problem solving skills
The ideal candidate is persuasive, effective and flexible in personal interactions at all levels. with strong oral and written communication skills

Director, Clinical Research Resume Examples & Samples

Provide medical/clinical research expertise
Lead and design protocols
Evaluate safety and efficacy data
Analyze and summarize data for presentation to senior management and regulatory agencies
Provide assistance and support in managing relationships with regulatory affairs, biometrics and other non-clinical departments within Gilead
Provide strategic guidance and designs on non-regulatory clinical trial plans

Director / Senior Director, Clinical Research Resume Examples & Samples

Lead the creation of clinical strategies and development plans for assigned programs across development phases, in consultation with cross-functional team members and outside consultants, to meet all requirements of the product development strategy
Be the recognized clinical expert for these development program/s both within and external to Ironwood
Serve as a medical monitor for clinical studies (provide medical oversight of the study; answer questions about eligibility; review safety and adverse event information), working closely with cross-functional team members, including external partners, to ensure planning and execution of clinical trials to meet key milestones, maintain timelines and keep within agreed budget
Assist in the preparation of clinical protocols and FDA/EMA documents (eg., INDs, annual reports, meeting requests, briefing books, and NDAs) and other relevant clinical documents
Play a key role in the development of analysis plans, and in the review, interpretation and communication of clinical trial data from Phase I to III safety and efficacy trials; assist in generating the study reports and publications from these trials
Provide clinical, scientific and development expertise to business development initiatives
An MD or DO degree
Medical expertise in internal medicine
A minimum of six years of pharmaceutical/biotech-industry experience in clinical research and development, ideally with experience across Phases 1-3 and post-approval; for Director, a minimum of three of relevant industry experience
Possesses thorough understanding of strategic and operational aspects of clinical research and product development
Strong general knowledge of regulatory requirements such as apply to clinical drug development, with significant experience interacting directly with Health Authorities
Translational medicine expertise a significant plus (not required)
Persuasive, effective and flexible in interpersonal interactions at all levels, with strong oral and written communication capabilities
Strong project management and problem-solving skills
Specialty training and board certification, or expertise in rheumatology or nephrology would be ideal, but is not required
Displays sense of urgency, and a willingness to be a “player/coach” able to roll up sleeves to get the work done when necessary

Senior Director, Clinical Research Resume Examples & Samples

Lead the creation of clinical strategies and development plans for assigned programs in Phase I, II, or III of development, in consultation with cross-functional team members and outside consultants, to meet all requirements of the product development strategy
Provide medical input into the design of clinical trials for these development programs
Serve as a medical monitor for clinical studies (provide medical oversight of the study; answer questions about eligibility; review safety and adverse event information), working closely with cross-functional team members to ensure planning and execution of clinical trials to meet key milestones, maintain timelines and keep within agreed budget
Establish strong Scientific Advisory Groups of external thought leaders to support the development of compelling clinical development strategies and help optimize program plans and protocols
Collaborate with other members of the Clinical Affairs and broader R&D teams on medical matters related to drug development
Support pre-clinical development planning and translational medicine efforts to effectively advance pipeline programs
Provide clinical, scientific and development expertise to business development initiatives as needed

Director, Clinical Research Oncology Resume Examples & Samples

Establishing communications with prominent clinical investigators in his/her particular field of interest, particularly those who will be willing and able to assist in the evaluation of Merck drugs
Attending appropriate scientific meetings to maintain his or her competency and to maintain awareness of research activities in his/her area of responsibility
Must have experience in industry or senior faculty in academia
A proven track record in clinical medicine and background in biomedical research is essential

Director, Clinical Research, Oncology Resume Examples & Samples

Maintaining awareness of scientific developments within his/her area of expertise, in terms of new scientific findings, research methodologies
Identification of scientifically and operationally strong investigators who can assist in the development of Merck's investigational and marketed drugs
Establishing communications with prominent clinical investigators in his/her particular field of interest, particularly those who will be willing and able to assist in the evaluation of Merck drugs; and
Strong interpersonal skills, as well as the ability to function in a team environment

Director, Clinical Research Resume Examples & Samples

Manages the US Clinical Research staff in planning, conducting, and reporting clinical studies
Ensures that studies are conducted in compliance with applicable requirements, including department Standard Operating Procedures (SOPs), corporate policies, and regulatory requirements and guidelines (e.g., Good Clinical Practice and Good Laboratory Practice)
In cooperation with the other site Directors and the Head of Global Clinical Research, participates and contributes to the establishment of policies and SOPs within Global Clinical Research
Ensures co-operation of this department with other MAH departments
Monitors the activities and budgets on projects being conducted in the US Clinical Research group. Identifies when resource, time, and/or budget constraints occur and works with the US Clinical Research Team to identify solutions
When applicable, directly lead clinical research studies
Support the Project Managers in providing resources to conduct clinical studies and to participate in project team meetings
Provide technical and scientific support to Regulatory Affairs for existing products and products in the registration phase
Provide technical support to global, regional or local Marketing particularly in the launch phase of new products / indications
Lead the implementation of new processes or technologies in the US
Prepare scientific publications (article, posters or oral communications in congresses) of study results when requested
Maintain scientific know-how in the relevant areas in reviewing relevant scientific literature and in attending scientific and veterinary conferences
Guide, motivate and develop staff in the US
Make personnel decisions in agreement with the Head, Global Clinical Research
Ensure efficient organization structures and operation procedures in the area of delegation
Minimum 10 years of experience in clinical research or equivalent
A strong ability in scientific writing
Computer literate (Word, Excel etc.)

Associate Director, Clinical Research Resume Examples & Samples

Assist Senior Director, Clinical on developing of clinical program for projects
Develop and review of clinical protocols, review of scientific literature, work with physicians and external consultants to develop clinical design and project strategy
Review and analyze clinical trial data, prepare scientific conclusion for study results
Lead all necessary activities including setting up, monitoring and reporting of bio studies
Prepare clinical documents for IND/NDA/ANDA submissions
Select CROs, negotiate contracts, and maintain budgets and timelines
Manage CRO’s and other vendors; monitoring and audit activities to ensure studies compliance with GCP/ICH guidelines
Support regulatory department in response to FDA deficiency letters
Develop study specific training documents and investigator’s brochures
Conduct monitoring and co-monitoring activities
Participate in the development of implementation of clinical trial documents
Support Regulatory department in response to FDA deficiency letters
Maintain current knowledge of relevant regulations, including proposed and final rules
Interface with various departments including R&D, Regulatory Affairs, Pharmacovigilance, Marketing and Sales
Assist in developing clinical plans and requirements for new products
M.Sc. in pharmacy or life sciences or higher degree
Knowledge of Clinical Development Process
7+ years of experience in the pharmaceutical industry
Strong partnering and collaboration skills

Director, Clinical Research Resume Examples & Samples

Directing and implementing clinical research plans (CDP) and programs according to established design principles
Directing the integration of the CDP and drug development plans - Leading the development of clinical protocols to meet CDP objectives
Serving as a Study Director and driving the execution of the study from protocol concept to final report, including interpretation of clinical data
Serving as the Medical Monitor for the overall clinical program to review and monitor study safety data
Serving as subject matter expert to provide direction to all project team functions, organizing Advisory Board Meetings (e.g.) agenda setting, and identifying and liaising with key opinion leaders regarding program strategy and scientific advice
Contributing clinical expertise and content to regulatory documents (e.g., briefing books, NDAs, etc.)
MD required with Board Certification in Psychiatry, Neurology or Sleep Medicine preferred
3 - 5 years of clinical research in Neuroscience within a pharmaceutical environment
Study-specific experience in the areas of Sleep Disorders and/or Alzheimer's Disease is desirable but not required
Experience conducting clinical trials and basic knowledge of regulatory requirements is required
The ability to manage the complexities associated with co-development efforts and work cross functionally with a collaborative style that builds alliances and emphasizes Eisai Core Values (integrity, respect, professionalism, quality and teamwork) in a fast paced environment
Occasional travel to Investigator Meetings; up to 20% travel

Director, Clinical Research Resume Examples & Samples

Serving as the Medical Monitor, depending on qualifications, for the overall clinical program to review and monitor study safety data
MD required
3-5 years of experience depending upon credentials, in pharmaceutical clinical research or clinical scienctific background, preferably with experience in neuroscience and especially dementia (e.g., Alzheimer’s disease)
A thorough understanding of clinical research methodology including study design, protocol writing, and CRF preparation
Knowledge of GCP and local regulatory requirements
Knowledge of medical, scientific and clinical research techniques in the neurology/psychiatry therapeutic area
Knowledge of the role of biomarkers and neuroimaging in evaluating pharmacodynamic effects and proof-of-pharmacology

Associate Director, Clinical Research Resume Examples & Samples

The CRM is the country point of contact (POC) for assigned protocols 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/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
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
Strong communication, diplomatic and empathic skills
Strong organizational skills with demonstrated success required
Negotiation skills with both internal and external groups
Experience with managing clinical trials within a country from site selection to site close out
Experience working in a matrix environment
Experience in Infectious Disease studies

Senior Director, Clinical Research Operations Resume Examples & Samples

Ensure that all clinical research activities are in compliance with appropriate regulations, (including FDA, CFR, IDE guidelines, HIPAA, Conflict of Interest and Institutional policies)
Efficient management of resources to ensure fast patient recruitment, trial plan optimization, and execution of trials, taking advantage of existing institutional infrastructure where appropriate
Provide assistance, training and supervision for regulatory staff, research coordinators and research nurses
In conjunction with the UAHS Research Administration Office, oversee the centralized regulatory support team and coordinate submissions to the Human Subject Protection Program (IRB), including completion of regulatory paperwork as needed amendments, revisions, INDs, IDEs, Medicare Intermediary approvals, 1572s
Oversee the Department of Medicine clinical research /clinical trials operations and performance
Work directly with faculty to ensure that they have support in the design, implementation and execution of their research protocols
Provide other appropriate assistance to ensure quality and timely completion/submission of case report forms and other study management reports
Develop and implement Standard Operating Procedures for clinical research operations
Demonstrated skills in leadership and team-building
Ability to accommodate and respond to shifting priorities and multiple, demanding projects, in a manner that is effective and efficient
An established record of personal and professional ethics, character and integrity
BA or BS in Business, Finance or related field of study required, and eight (8) years of experience in a research/clinical research compliance
Certifications in Phlebotomy, IATA Shipping, Blood Borne Pathogens and Good Clinical Practice
Experience working within a university research or academic medical center compliance office, or healthcare organization with significant university research contacts
Expert knowledge of key compliance regulations, including those related to clinical research and use of human subjects
Successful, proven experience in administrative leadership within academia, or in a comparable position

Director, Clinical Research ID / HIV Resume Examples & Samples

Responsible for clinical research protocol development and medical/scientific oversight of clinical trials (Phases 2-4) involving experimental or marketed drugs in the infectious disease clinical research group
Participates in all phases of clinical development process for Merck Research Laboratories sponsored studies including study design, medical monitoring and medical/scientific interpretation of study analyses for both efficacy and safety non-study safety reports and scientific and regulatory document authoring
Apply an in-depth understanding of the disease under study and provide input to the development and implementation of short and long-term objectives of the infectious disease clinical research group
Provide internal scientific leadership for cross functional areas supporting clinical development and external leadership through interaction with study investigators
Infectious disease/HIV background and/or experience in clinical trials of infectious disease drugs (preferably HIV)
Demonstrated ability to work as part of a high performing team

Senior Director, Clinical Research Resume Examples & Samples

MD required, with Board Certification
10+ years of experience in pharmaceutical clinical development, with experience in Neurology and Phase II-III, global, multicenter studies
A thorough understanding of clinical research methodology including study design, protocol writing and study report preparation
Direct measurable experience in the Medical Affairs discipline, interacting with KOLs, research centers, etc
Experience/active participation in LCM and commercial development activities
Working knowledge of the IND/NDA/CTA/MAA processes acquired through direct industrial experience
Knowledge of medical, scientific and clinical research techniques in the neurology area
Prior experience participating in the selection of new compounds for clinical development and IND filing in Neuroscience through technical evaluation of licensing and/or partnership opportunities
Experience developing and implementing paradigms for novel data analysis

Associate Director Clinical Research Informatics Resume Examples & Samples

Oversees data management design and implementation (including data collection, enrichment, tracking, intake and export), ensuring adherence to milestones and deliverables
Leads on defining the strategic data collection, storage, management, tracking, sharing and integration requirements and plans for the Study; data could be subject information or research data
Leads on executing projects that support the development of data collection, storage, management, tracking, sharing and integration systems (key projects to support will include, systems to support subject tracking and outreach management, in-person assessments tracking and data needs and systems, remote data collection data needs and systems, and biospecimen data collection needs and systems)
Acts as key liaison between research team and data platform and tools team to ensure all study team requirements are appropriately translated and executed
Partners with Study’s research staff to understand data management and systems needs and translates requirements to appropriate parties (i.e., vendors, consultants, internal resources)
Oversees the development and build of new approaches for data intake and data export and sharing with external parties (e.g., co-investigators, study subjects, etc)
Works closely with co-investigators and the appropriate parties in their organizations to understand and define data needs, requirements and systems for sharing and integration with FPHS systems
Serves as key liaison with informatics and data teams from across the university, partnering hospitals and other institutions to define and execute projects
Develops requirements for and maintains and refines processes and systems to support designated program and project work
Oversees and manages relationships with vendors and consultants as required
Supports the development of IRB research protocols as necessary
Leads weekly meeting of research team and data platform and tools team
Defines data management and systems staffing requirements as the program grows and shifts
Hires and supervises data management and systems staff
Represents project to the faculty and staff of Harvard and other external stakeholders as needed (e.g., at internal meetings, board meetings, conferences)
Other related duties as assigned
Bachelors degree in bioinformatics, medical science, management or health care related field
Eight or more years of related experience preferably in an academic, health care, or other complex environment or an equivalent of education plus relevant experience is required
Five or more years of experience managing clinical research
Five or more years human subjects study management
Knowledge of, interest in and experience with long-term research studies, clinical trials and/or sports medicine
Proven program management skills including an ability to manage multiple projects and coordinate staff
Proven data management skills and experience
This position requires specific technical skills in database systems and database design
Familiarity with SQL, SAS, R and/or similar tools
Proficiency with relational database systems
Solid understanding of research data system implementation best practices and appropriate use of design patterns
Excellent organizational, interpersonal and communication skills are essential
Excellent computer skills, including knowledge of Microsoft Office and Outlook
Ability to work across teams and with a variety of projects and constituencies
Previous experience in academia or health care will be highly valued
The successful candidate will have a proven track record of executing and delivering on projects in a complex and shifting environment with multiple and at times conflicting interests
The successful candidate must have the ability to exercise good judgment on a range of issues, many of which are confidential in nature, and to manage complex projects through to completion

Associate Director Clinical Research Resume Examples & Samples

A minimum of a Bachelor's degree is required
Advanced degree (MD, MS, RN, RD, PhD or PharmD) is preferred
A minimum of at least 3 years of clinical research and development experience within the Pharmaceutical, Medical Device OR CRO industry or experience as clinical research coordinator in non-industry setting is required
Independent decision-making and analytical skills are required
Travel up to 20% of time both domestic and international is required

Associate Director Clinical Research Resume Examples & Samples

You possess a Bachelor’s or higher degree, preferably in Life Sciences (e.g., Biology, Chemistry, Nursing, and Pharmacy)
You have 8 or more year’s clinical trial experience in the pharmaceutical/ medical device industry and or CRO
You are able to lead all aspects of execution of a clinical trial and you demonstrate expertise in vendor management
You excel in organizing and motivating global or regional teams in a virtual environment
You are a coach and a mentor
Able to travel up to 20% of the time, (as defined by business need)
Experience executing Phase II & III clinical trials
Relevant experience in associated Therapeutic Area

Site Director, Clinical Research Resume Examples & Samples

B.A. or B.S. required, advanced degree preferred; minimum of 5+ years progressive experience in managing a Phase I clinical research facility
At least 10+ years prior experience in Phase I clinical research preferred
Understanding of Clinical Research Requirements: Familiar with clinical research study processes and requirements. Understands regulatory requirements, as well as Good Clinical Practices (GCP) and International
Conference on Harmonization (ICH) guidelines
Communication: Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner. Knowledgeable in medical terminology so as to communicate with physician office and laboratory staff. Skilled in persuading potential sponsors to place research with the site
Management: Able to manage a staff of clinical professionals and create a productive, satisfying work environment
Independence: Demonstrates the initiative to act independently, initiating activity as required and making appropriate decisions within the constraints of study protocols, regulatory requirements, this job description, and company policy
Adaptability: Able to initiate or modify behavior to achieve desired outcomes in spite of environmental factors, priorities, or problems that might not be well defined or that are subject to change
Computer Skills: Able to use standard office software, as well as proprietary applications unique to the clinical research industry and individual sponsoring organizations

Director, Clinical Research Finance Resume Examples & Samples

5) Lead and direct the OCR Finance Manager and staff to establish procedures for effective monitoring of patient enrollment, cash position (A/R) and overall appropriate study expenditures through to close out and residual transfer if applicable
6) Oversee the financial health of clinical trial activity within Penn Medicine. Report to Senior Leadership with annual plan including multi-year forecasts, including overall clinical trial activities, level of faculty engagement, ranges of sponsorship, etc
7) Responsible for execution and maintenance of research financial and compliance training for Clinical Trials administration throughout Penn Medicine
8) Ensure financial compliance with institutional, federal and non-federal policy, rules and regulations
9) Provide leadership and direction for the financial training and professional development to Departmental BAs and OCR Finance Unit

Director, Clinical Research, Vaccines Resume Examples & Samples

Board certified or eligible in a vaccine-related clinical field such as Internal Medicine, Obstetrics Gynecology, Family Medicine,or Pediatrics
Clinical Research experience with evidence of strong scientific productivity such as authorship on published manuscripts
Excellent communication and writing skills

Director, Clinical Research Operations Resume Examples & Samples

Bachelor's degree required. Preferably in clinical healthcare field (BSN, RPh) or healthcare Administration, business, science or related field
Master's degree or higher preferred (PhD, MBA, Pharm.D., MSN)
Ten (10) years of current clinical research operations management experience, preferable in a hospital setting may substitute for master's education
5-8 years of healthcare management experience in a multi-specialty research and/or inpatient healthcare provider environment
5 years of progressively responsible management experience

Director Clinical Research Resume Examples & Samples

Oversight of productivity and quality standards for the Infusion Center
Oversight for nursing and physician research studies
Facilitate Care Assure program at the facility level
Manage special projects with an emphasis on research, quality and patient safety approach
Promote harmony and builds rapport with physicians, patients, families, peers and customers
Serve as a role model to promote excellence and safety in accordance with Evidence Based Practice
Work closely with nursing leadership to monitor adequate compliance with procedures related to regulatory agency standards, national patient safety goals and sentinel alerts to promote a safe environment of care, reports failures and initiates corrective action when appropriate
Current FL RN license
BSN required, MSN strongly preferred
5+ years nursing experience in the acute hospital environment
Minimum 2 years in a leadership/management capacity
Minimum 1-2 years teaching/instruction/adult clinical learning experience in a similarly sized health care system or acute care facility
Clinical Research experience preferred
Event Coordination and Poster preparation experience

Director Clinical Research Operations Resume Examples & Samples

Provides direct leadership and management for PHC research operations team members
Recruits, hires, and develops professional staff as needed to support an effective research administrative infrastructure
Creates effective training programs, policies, and processes to ensure work standardization and research team and key stakeholder understanding of ethical and regulatory guidelines
Continuously evaluates research program compliance, quality, and effectiveness, identifies, and develops opportunities for improvement that provide greater value for stakeholders
Leads process improvement and organizational change initiatives toward program optimization
Partners and collaborates with the PHC Compliance office to evaluate and address research compliance issues and risks
Reviews existing and, as necessary, develops new policies and procedures to ensure compliance with all applicable institutional, local and federal regulations, and PHC policies
Encourages expanded participation from existing physician investigators through action oriented and expert support and helps to inspire and support new investigators in the sponsored research program
Organizes and structures PHC research administrative services to expand the capacity of the research program with a focus on increasing and diversifying sources of revenue and financial support
Directs an effective system of marketing and communication across PHC, the research community, and key stakeholders, to build and promote a positive image of PHC sponsored research
Oversees the identification, evaluation, development, and implementation of technology to support sponsored research
Coordinates with research financial administration and accounting and is responsible for ensuring the financial viability of the overall research program
Monitors and reports on the performance, compliance, and general operation of the PHC sponsored research program
Develops annual research operation budgets and strategic initiatives aligning with PHC’s strategic plan
Supports and executes on the strategic focus of key research service lines working with their respective administrative and physician leads
Effectively collaborates and coordinates with key ancillary clinical and non-clinical services including revenue cycle, supply chain, laboratory services, imaging services, and others

Director Clinical Research Resume Examples & Samples

A minimum of at least 5 years of clinical research and development experience within the Pharmaceutical, Medical Device OR CRO industry or experience as clinical research coordinator in non-industry setting is required
Clinical research operational knowledge, strong project planning/management and excellent communication skills is required
Ability to operate with limited day to day supervision is required
Experience in Neuroscience Therapeutic Area is desired
Successful work experience in a matrix team environment with cross functional teams is required

Director, Clinical Research Resume Examples & Samples

Serves as Study Director for a study or clinical program; including review of study safety data and implementing strategies to identify, monitor and resolve clinical program/ trial issues. Leading the Clinical Subteam
Serving as a SME to provide direction to all project team functions, Organizing Advisory Board meetings (e.g., agenda setting), and identifying and liaising with KOLs regarding program strategy and scientific advice
Ph.D required, ideally in Neurology or Psychiatry
A minimum of 7-10 years in pharmaceutical clinical development with experience directing Neurology Phase II-III global multicenter studies
Knowledge of scientific and clinical research techniques in the neurology area

Assistant Director, Clinical Research Resume Examples & Samples

Prior Oncology clinical trials experience and working knowledge of NCTN cooperative group system
Experience with monitoring and/or auditing
Research certification (ACRP/SOCRA)
Experience with Excel, PowerPoint and Word
Must work independently, interact professionally, interpret complex policies and procedures and possess effective technical writing and organizational skills

Director, Clinical Research Resume Examples & Samples

Must have experience in industry or academia
Demonstrated record of scientific scholarship and achievement
Prior specific experience in clinical research and prior publication is desirable but not necessary
Strong interpersonal skills, as well as the ability to function in a team environment are essential

Director, Clinical Research Resume Examples & Samples

Must have a minimum of 2 years of experience in industry
Training and expertise in molecular imaging and biomarkers in cancer developmental therapeutics
Prior specific experience in clinical research and prior publication

Director, Clinical Research Dermatology Resume Examples & Samples

Participate in setting the drug development strategy for the Dermatology clinical program
Play a significant leadership role, as well as provide “hands on” work and work in collaboration with relevant team members and peers to ensure the highest level of execution for Dermatology clinical development programs
Clinical Study Design and Execution
Experience on teams with early and late stage development products (Phase 3 to regulatory submission)
Experience leading Medical Advisory Boards
Strong project management skills, business savvy and business development experience is desirable
Strong interpersonal skills, a collaborator/ team player, open minded to the diverse opinions of others
Ability to produce highest quality timely clinical development work product/document with limited direction under tight time constraints
Hands-on performer, ensuring strong execution of clinical trials and other drug development activities
Flexibility and adaptability, able to thrive in small biotechnology company environment
A superior work ethic and a strong personal desire for success. He or she must also possess a strong sense of personal and professional ethics
A good balance of confidence and humility
Must be passionate about developing treatments for rare/orphan diseases

Senior Director, Clinical Research Services Resume Examples & Samples

Demonstrated expertise in a variety of fields related to the conduct and management of clinical oncology, HIV/AIDS and Diabetes research
Development and effective implementation of performance metrics which drive cost efficiency and optimal results
Reliance on experience, expertise and judgment to define and accomplish goals
Facilitated communication among leaders and stakeholders at all organizational levels
Lead and direct the work of others to oversee the conduct innovative clinical trials and advance the standard of care towards best practices in clinical research
Bachelor’s degree, Master’s degree preferred
Seven years of progressive clinical trial administrative management experience in a large, complex organization
Sound financial background in an academic or non-profit setting
Experience at a non-profit and/or higher education medical center is required with knowledge of oncology clinical trials
Experience with Epic EHR system and OnCore CRMS
Strong experience financially managing a large portfolio of industry-sponsored and non-industry sponsored clinical trials
Strong knowledge of clinical research, including Medicare coverage analyses and clinical trials budgeting and federal guidelines/regulations pertaining to clinical research
Demonstrated knowledge of Electronic Health Records System and Clinical Research Management System
Must be detail-oriented with strong problem-solving skills
Must have the ability to work closely and effectively with a diverse group of administrators; strong interpersonal and leadership skills; proven ability to effect and influence change through a collaborative and inclusive style
Expresses commitment to City of Hope’s mission, personally identifies with its vision and takes pride in shared success
Exhibits flexibility while influencing others to improve processes and implement changes
Anticipates needs, responds quickly, provides guidance and support, monitors and follows up as required