The Clinical Project Manager is responsible for the strategic planning, implementation and management of multiple smaller studies of varying complexity or larger clinical trials across indications or programs. This includes overseeing clinical trials from study design through close out; establishing and managing relationships with assigned investigator sites, vendors and consultants to ensure timelines and deliverables are met and that studies are conducted in accordance with appropriate regulatory requirements. The Clinical Project Manager is also responsible for leading or contributing to company process improvement initiatives.
Primary Duties and Responsibilities:
- Leads efforts for the selection and oversight of external service providers, including CROs, Central Laboratories, IRT's (IWRS) and other vendors as necessary.
- Independently manages responsible study(ies) within agreed timelines and budget and in accordance with internal SOP's and GCP/ICH guidelines and other regulatory requirements and coordinates cross functional efforts to achieve study objectives and goals.
- Develops study budget(s); participates in vendor/site budget negotiations and assists with Clinical Trial Agreements as necessary. Develops and maintains study budget tracking tools to ensure that trial costs are accurately tracked and reported.
- Develops and oversees study quality metrics to ensure that subject recruitment goals are met.
- Identifies and communicates study issues that will impact budget, resources and timelines. Provides support/escalation point for study team leads as needed.
- Establishes and maintains relationships with assigned investigator sites, vendors and consultants.
- Prepares potential investigator site lists and assists with their evaluation for inclusion in the study, ensuring proper prequalification of clinical sites.
- Prepares or oversees preparation of documentation for assigned trials, e.g., study manuals, monitoring plans, communication plans.
- Recommends strategies for, and oversees, the execution of activities associated with clinical monitoring, safety, eligibility, enrollment, and data consistency.
- Participates in the review and finalization of other clinical study-related documents such as protocols, protocol amendments, Clinical Study Reports (CSRs), regulatory submissions, and other publications as required.
- Ensures documentation prepared internally or by CRO(s) is completed in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies/programs.
- Participates in the ongoing and final review of clinical study data to ensure the data is accurate and complete, and assessment of the impact of this data to the study and program.
- Ensures Trial Master File is accurate and up to date.
- Mentors more junior team members.
- Leads and/or contributes to department initiatives and assists in the design and implementation of standardized work processes.
- Qualifications:Interpersonal Skills - Must have strong leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner.
- Communication Skills - Excellent oral and written communications.
- Productivity/Organizing/Planning – Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously.
- Strategic Thinking – Strong capable of strategic thinking and proposing innovative solutions to issues.
- Collaboration & Teamwork – Advanced competence in collaboration & teamwork, communications, influence, strategic agility, planning & organizing, driving results and problem solving. Ability to work independently and in a team environment.
- Education and Experience Requirements:Bachelor's degree in a scientific discipline.
- Minimum of 6+ years of clinical study management experience in a pharmaceutical, biotechnology, Contract Research Organization (CRO) or related environment, including a minimum of 2 years as a clinical study lead / project manager is required; global clinical trial experience is highly preferred.
- Experience working with CRO's required; experience with central laboratory and IRT set up and management highly preferred.
- Multi-study experience managing early through late stage clinical trials.
- Working knowledge of, and experience with, clinical trial design, conduct, data acquisition and reporting.
- Working knowledge and understanding of key regulatory authorities, ICH Guidelines and Good Clinical Practice (GCP).