Overview:This role independently leads the execution and management of clinical studies from study design and start-up through completion, serving as a key point of contact for internal teams, study sites, vendors, and other clinical partners.
Responsibilities:- Collaborates on clinical study design with goal to serve as subject matter expert (SME).
- Responsible for the development of all clinical documents including but not limited to the clinical study protocol, case report forms, informed consent forms, clinical study agreements, investigator manuals, investigator files, and all other necessary documentation for study initiation (the development of several clinical documents falls under the responsibility of other clinical functions in the EU).
- Independently responsible for all clinical study activities including but not limited to primary contact for internal/external clinical customers (such as Monitor, Data Manager, clinical study sites, etc.), leads clinical study team meetings, establishes and manages the study timeline, anticipating schedule impacts and adjusting project team activities where required.
- Facilitates completion of regulatory submissions and drafts written submissions/responses for regulatory bodies as needed.
- Ensures the project team maintains a continuous state of audit readiness
- Aware of Institutional Review Board (IRB) / Ethic Committee (EC) reporting requirements.
- Establishes plans for escalation and/or field assurance issues; assesses key protocol-specific parameters and escalates as appropriate.
- May participate on a cross-functional core team.
- Collaborates with Quality and other Risk Management stakeholders contributing to the proactive identification, assessment, and management of clinical study risks.
- Acts as a point of contact for vendors including but not limited to managing the vendor selection process, review/initiate the vendor contract and payments.
- Establishes and manages the clinical study budget, collaborating impacts/risks to timeline and budget; may work directly with Finance partners.
- Responsible for site management including but not limited to site qualification, initiation, and non-compliances.
- Independently submits clinical studies to ethical boards when needed.
- Responsible for developing trainings and ensuring team members are trained (responsible for developing all trainings and training of all team members in the US).
- May deliver Health Care Provider (HCP) presentations.
- Creates cross functional collaboration workflows to support milestones.
- May verify, review, and track CRFs.
- Ensures that centralized data reviews are conducted and is involved in query resolution with the site, where required.
- Collaborates on clinical study reports based on study management and/or tracking needs.
- Liaisons with the Statistician.
- Ability to travel domestically and internationally up to 30% of the time.
