What are the responsibilities and job description for the Clinical Project Manager position at Custom Search?
Our small, well-funded start-up client is adding a Clinical Project Manager to the team. The Clinical Project Manager will report to the VP Clinical (lives in MN) and will be a remote role with minimal travel. The Clinical Project Manager leads the planning, development and execution of the clinical research trial(s). Ensures compliance to study protocol, Good Clinical Practices, applicable domestic and international regulatory standards, and Standard Operating Procedures. The Clinical Project Manager will participate in development of Standard Operating Procedures, selection and implementation of systems (eTMF, EDC) to support timely reporting of data for senior management. Participates in the preparation of regulatory submissions. Has established a high degree of competence in clinical research and has experience in all aspects of a clinical research program. Functions independently with a significant degree of autonomy.
Your role with the company :
- Ensure that internal and external clinical study teams fulfill their responsibilities in accordance with regulatory policies, Good Clinical Practices, procedures and / or guidelines during clinical trials.
- Oversee the planning and execution of all phase of clinical studies to ensure that deliverables are completed on time and within budget.
- Develop an understanding of competitive landscapes for assigned products and therapeutic areas.
- Develop and execute project plan, manage study time and ensure activities are conducted in order to achieve
scheduled milestones and goals.
on-time, within budget, and are consistent with the scope of work.
manuals, monitoring plan, informed consents, recruitment materials, clinicaltrials.gov, and other study related tools.
agencies' questions regarding the clinical study.
Desired Profile :
