Clinical Trial Manager
A Clinical Trial Manager oversees the administration and progress of clinical trials, ensuring adherence to regulatory requirements and protocols, and manages the clinical operations team.
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Sample Job Descriptions for Clinical Trial Manager
Below are the some sample job descriptions for the different experience levels, where you can find the summary of the role, required skills, qualifications, and responsibilities.
Junior (0-2 years of experience)
Summary of the Role
The Clinical Trial Manager is responsible for the overall coordination and management of clinical trials from start to finish, ensuring compliance with protocol and regulatory requirements. The Junior Clinical Trial Manager will work under supervision to support various aspects of trial conduct and site management.
Required Skills
- Strong analytical and problem-solving capabilities.
- Proficiency with clinical trial software and databases.
- Knowledge of GCP and ICH guidelines.
- Attention to detail and accuracy in handling and documenting clinical data.
- Competency in Microsoft Office suite.
Qualifications
- Bachelor's degree in life sciences or related field.
- Understanding of clinical trial processes and regulatory requirements.
- Experience in clinical research or a related role preferred.
- Excellent organizational and communication skills.
- Ability to manage multiple priorities and adapt to changing priorities.
- Ability to work collaboratively in a team environment.
Responsibilities
- Assist in developing and managing study protocols.
- Participate in site selection, initiation, monitoring, and close-out visits.
- Work with the study team to ensure compliance with the study protocol and FDA regulations.
- Assist with the management of study timelines and milestones.
- Help to coordinate communication between the study site and the study team.
- Support data management and analysis efforts by compiling data and tracking outcomes.
- Assist in preparing reports and presentations for stakeholders.
- Coordinate the ordering, tracking, and management of study supplies.
Intermediate (2-5 years of experience)
Summary of the Role
The Clinical Trial Manager is responsible for overseeing the administration and progress of clinical trials in accordance with protocols and regulatory requirements. This role involves coordinating the efforts of trial teams, managing patient data, ensuring compliance with good clinical practice, and often interacting with regulatory bodies.
Required Skills
- Strong leadership and team management abilities.
- Excellent organizational, communication, and problem-solving skills.
- Proficiency with clinical trial management software and electronic data capture systems.
- Ability to work independently and collaboratively in a fast-paced, demanding environment.
- Attention to detail and commitment to high-quality data collection and reporting.
Qualifications
- Bachelor's degree in life sciences or related field; advanced degree preferred.
- Minimum of 2 years of experience in clinical trial management or related field.
- Knowledge of regulatory requirements relating to clinical trials, including FDA and ICH guidelines.
- Experience with clinical trial design, implementation, and management.
- Proven ability to manage multiple projects and priorities simultaneously.
- Strong understanding of data management and statistical analysis within the context of clinical trials.
Responsibilities
- Designing, planning, and implementing clinical trials in line with regulatory requirements.
- Coordinating the activities of the trial team, site staff, and outside vendors to ensure compliance with the study protocol.
- Monitoring study performance and making adjustments as necessary to maintain trial quality and integrity.
- Ensuring that patient recruitment and retention targets are met while upholding ethical standards.
- Managing and reporting on trial budgets, including tracking expenses and ensuring financial efficiency.
- Preparing for and responding to audits by regulatory authorities and ethics committees.
- Maintaining open communication with stakeholders, including sponsors, regulatory agencies, and institutional review boards.
- Analyzing data and preparing interim and final reports on trial outcomes.
Senior (5+ years of experience)
Summary of the Role
Seeking an experienced Clinical Trial Manager to lead and oversee clinical trials. The ideal candidate will have a strong background in clinical research, with a proven track record of successfully managing all aspects of trial conduct from startup to closeout.
Required Skills
- Excellent organizational and project management skills.
- Strong leadership and team management skills.
- Outstanding communication and presentation skills.
- Ability to solve complex problems and think analytically.
- Proficiency in MS Office and clinical trial software.
Qualifications
- Bachelor's degree in life sciences or related field; advanced degree preferred (e.g., Masters, MD, PhD).
- Minimum of 5 years of clinical trial management experience.
- Thorough knowledge of FDA regulations, Good Clinical Practice (GCP), and ICH guidelines.
- Prior experience with electronic trial management systems.
- Demonstrated leadership in a clinical research setting.
Responsibilities
- Develop and execute trial strategy in line with clinical development plan.
- Lead and manage the clinical operational aspects of trials to ensure compliance with GCP and regulatory requirements.
- Coordinate with cross-functional teams to ensure trial milestones are met.
- Manage trial budgets and resources effectively.
- Act as the primary liaison between the company and external stakeholders including investigators and regulatory bodies.
- Identify, select, and oversee external vendors and clinical sites.
- Monitor trial progress and prepare reports on trial status.
- Manage and mitigate trial risks and issues proactively.
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