Clinical Trials Manager Job Description
Clinical trials manager
provides compliance guidance on the conduct of clinical research in accordance with GCP/ICH/FDA and International regulations and standards.
Clinical Trials Manager Duties & Responsibilities
To write an effective clinical trials manager job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical trials manager job description templates that you can modify and use.
Sample responsibilities for this position include:
Participate in periodic review and revision of departmental policies and SOPs to assure compliance with GCP and corporate policies
Participate in periodic review and revision of departmental policies and SOPs to ensure compliance with GCP and corporate policies
Manage/oversee the conduct and execution of assigned clinical trials and associated activities
Interact with internal and external groups to facilitate clinical trials and achieve designated timelines
Oversees study timelines
Oversee and participate in review of clinical trial data and clinical trial files
Participate in special projects as appropriate
Maintain professional and technical knowledge by staying current on pharmaceuticals industry research and developments
Assist with the review and determination of appropriate site and vendor selection
Keep management informed by escalating issues requiring intervention to the study and project teams
Clinical Trials Manager Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Clinical Trials Manager
List any licenses or certifications required by the position: PMP, ACRP, SOCRA, BLS, CCRC, CCRA, CCRP, PM, CIP, IBM
Education for Clinical Trials Manager
Typically a job would require a certain level of education.
Employers hiring for the clinical trials manager job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Education, Graduate, Nursing, Project Management, Health, Life Science, Science, Management, Biology, Business
Skills for Clinical Trials Manager
Desired skills for clinical trials manager include:
ICH Guidelines
GCP governing the conduct of clinical studies
FDA
EMA Regulations
GCP
ICH GCP regulations and clinical protocols
ICH guidelines and FDA regulations
Clinical research concepts
Good clinical practices and regulatory compliance
Transplant patient care and apheresis collection
Desired experience for clinical trials manager includes:
Responsible for designing, developing, and implementing tools, processes and strategies of a moderate to complex nature to track regulatory compliance, improve, and streamline regulatory processes essential to the successful management of clinical research projects related to clinical trials disclosure (specifically ClinicalTrials.gov and related clinical trial disclosure requirements)
Oversee and manage projects related to regulatory activities and clinical research operations, develop the regulatory strategy for project teams and maintain metrics
Lead efforts, authorize and manage submissions to internal and external agencies such as ClincalTrials.gov and similar registries
Provide ongoing training and guidance to regulatory and clinical research staff across the School of Medicine
Oversee, develop and facilitate educational and training programs for clinical research and regulatory staff, faculty and postdocs
Evaluate and analyze the impact on new regulations and determine how to implement within Stanford
Clinical Trials Manager Examples
1
Clinical Trials Manager Job Description
Job Description Example
Our growing company is hiring for a clinical trials manager. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for clinical trials manager
- Represent department or institute in interactions with external organizations such as industry sponsors or contract manufacturers and funding agencies, such as the National Institutes of Health
- Interact and advise senior management on clinical trials regulatory processes or decisions related to clinical trials disclosure
- Interacts with various study support groups in order to assist in clinical strategy, the development of study plans, and project deliverables
- Facilitates communication between Sales and Marketing, R&D, Regulatory Affairs, Training, Senior Management, Key Opinion Leaders/investigators and investigational sites by conducting team meetings, drafting and sending routine correspondence (e.g., newsletters) and by presenting regular updates to senior staff (BPT/PIB)
- Provides accurate progress reports on clinical projects by writing assigned clinical portions of reports for submission to regulatory agencies, Institutional Review Boards, Ethics Committees, May include clinical risk management activities including input into DFUs and authorship of Clinical Evaluation Report (CES, CRBA, CDSR) in support of the safety and performance of products
- May manage CPA/CTMA/Sr
- Be responsible for the overall coordination and management of clinical trials from start up to close out activities
- Direct the technical and operational aspects of the projects
- Work with major functional area leads to identify and evaluate fundamental issues on the project and ensure solutions are implemented
- Your professional interactions and communication skills with study sites and pharmaceutical partners
Qualifications for clinical trials manager
- Assure compliance with protocol requirements and complete necessary records
- Strongly prefer a professional with a wide-range of experience and expertise in a specialized technical field
- Ability to read, analyze and interpret professional journals, technical procedures, and/or government regulations in English
- A demonstrated track record of project managing large global trials within ideally a CRO and with General Medicine experience
- A demonstrated track record of project managing large global trials within ideally a CRO and with Hematology/Oncology experience
- A demonstrated track record of project managing large globaltrials within a CRO or Pharma environment within Respiratory Diseases
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Clinical Trials Manager Job Description
Job Description Example
Our company is looking for a clinical trials manager. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for clinical trials manager
- Develop and implement processes and procedures to perform activities in compliance with GCP and federal regulations and CTO policy
- Develop training programs in line with GCP guidelines
- Stay abreast of all Federal Regulations and ICH Guidelines and implement changes where applicable
- Your ability to work in a fast moving self-driven team
- Your ability to organize and coordinate documentation related to clinical trials running globally
- Participates in the recruiting and hiring process for CPA/CTMA/Sr
- Leads the execution of highly complex trials for the research team
- Acts as the scientific advisor to the sales and operations team
- Communicate effectively by establishing strong working relationships with a diverse matrix of clinical trial sites, investigators, pharmaceutical & biotechnology executives, registry executive committee members, and other important stakeholders
- Synthesize complex clinical, regulatory, and other clinical trial and registry information into actionable plans
Qualifications for clinical trials manager
- Strong written and verbal communication and working with global teams – setting clear expectations, ensuring proper follow-up
- A Bachelor's in a Scientific discipline is required
- A minimum of five to seven (5-7) years of professional experience within Clinical, Regulatory or another Scientific field is required
- At least 4 years of data management and/or related work experience in clinical trials operations
- Knowledge of the nature of the research done - Scientific, Medical and regulatory expertise
- Completion of Collaborative Institutional Training Initiative (CITI) Program
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Clinical Trials Manager Job Description
Job Description Example
Our company is looking for a clinical trials manager. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical trials manager
- Develop data management training and support resources for central data management staff
- Establish and oversee data quality management processes
- Create and manage data management workflows and project timelines to track progress of data management activities
- Establish strong communication pathways with the data operation team, project managers, statistical support and other internal and external stakeholders
- Serve as an escalation point-of-contact
- Serve as a subject matter expert for data management facilities and staffing for remote special projects
- Provide supervision for other LBR staff
- Perform other related duties as assigned by a responsible LBR authority
- This position requires approximately 10% travel to domestic and international locations
- Assist with implementation of research vision and goals
Qualifications for clinical trials manager
- Completion of Human Research and Health Information Privacy and Security Curricula for Biomedical and Clinical Investigators
- Experience as a research coordinator - preference for experience in lead role
- Experience in training staff, generating job descriptions, career path building
- Master’s degree in business administration, finance, or related field
- At least 3 years of related experience – preference for clinical trials budgeting and hospital finance experience
- Familiarity with hospital billing and CTMS software
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Clinical Trials Manager Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of clinical trials manager. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical trials manager
- Be responsible for ensuring the highest data quality, operations and staff management, quality assurance, regulatory compliance, data management, and strategic planning
- Work with CEO – PCCTC and lead management and staff to ensure appropriate funding and budgeting related to all aspects of clinical research
- Collaborate and integrate with the PCCTC participating PCCTC, LLCs in institutional efforts to improve the quality of clinical research across the consortium
- Serves as liaison for clinical trials conducted for pharmaceutical companies
- Monitors and reconciles the budget for all clinical trials
- Assists with the development of operating policies and procedures for clinical trials
- Determines and regulates research staff workloads and protocol assignments
- Organizes projects and collaborates with multidisciplinary team, including finance, GMP manufacturing, business development, clinical staff, and others as needed to complete assigned tasks
- Meet all established Company standards with respect to selling skills, product knowledge, account and territory penetration, competitive knowledge of market and competition, understanding of managed care, and reimbursement methodologies
- Assist the operational team with data collection from potential customers as needed
Qualifications for clinical trials manager
- Proficiency in MS Office Suite, in particular Excel
- 1 year experience in planning and managing clinical trial processes is preferred
- High school diploma or certified equivalence – Bachelor’s preferred
- Knowledgeable about email and basic computer use
- Willingness and ability to adapt or learn new skills as needed
- Experience in pharmaceutical clinical trials, including investigator initiated and cooperative group
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Clinical Trials Manager Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of clinical trials manager. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for clinical trials manager
- Act in a consultative capacity, assists customers to identify how Coram Clinical Trial’s services could facilitate problem resolution formulate a vision of adapting company services to their own requirements and specifications
- Set strategies and demonstrates a tactical sales plan with each account that results in the achievement of projected sales targets
- Demonstrate ability to close sales as evidenced by length of sales cycle, efficiency of sales process, and number of contracts signed
- Plan and organize a daily, weekly, and monthly work schedule to achieve optimum efficiency
- Assist as requested with the development of marketing and special event materials customer specific monthly and quarterly Quality Metric Reports
- Assist management in special assignments such as market tests, surveys, developing budgets, and territory breakdowns in assigned areas
- Complete and submit all required reports in a timely manner
- Maintain current account files and other records with respect to current and prospective customers in accordance with Company instructions and requirements
- Assist in collection of accounts receivable on an as needed basis
- Responsible for designing, developing, and implementing tools, processes and strategies of a moderate to complex nature to ensure regulatory compliance, improve, and streamline regulatory processes essential to the successful management of clinical research projects
Qualifications for clinical trials manager
- Knowledge of industry trends and experience in leading and driving operational programs and initiatives
- Excellent interpersonal, facilitation, negotiation and communication skills
- Demonstrated leadership skills, prior experience managing people
- Demonstrated ability to function in a highly matrixed team environment
- Bachelor's degree in life sciences, business or finance required
- Minimum of 8 years of experience with SAS programming