The Clinical Phase I Project Manager oversees and coordinates the operational aspects of ongoing clinical projects to ensure that the clients’ goals of time, cost, and quality are met. The Clinical Phase I Project Manager serves as the primary contact with the client to ensure appropriate communications, project budget management, and meeting of timelines. Senior leadership position in project management function responsible for the successful conduct of all client projects, including client satisfaction, operational delivery, clinical and technical patient care, and P & L responsibility. Responsible for driving process improvements within the project management function that supports larger organizational goals.
The position of Clinical Phase I Project Manager requires a Bachelor’s degree in life sciences, nursing degree, or equivalent, plus a minimum of three years of clinical research experience in a patient care setting. The position requires formal project management experience and a skill set developing process maps, site standard operating procedures and study-specific SOPs. Demonstrated knowledge and a clear understanding of the overall drug development process, including study initiation procedures, clinical monitoring functions, drug safety and regulatory issues, and report generation. Must have proficiency with ICH/GCP guidelines. Excellent verbal and written communication skills, organizational skills, time-management, customer service, and interpersonal skills are required.
The tasks of the Clinical Phase I Project Manager include but are not limited to:
- Ensure infrastructure project plan architecture ensuring on-budget, on-time completion of projects in adherence with client specifications.
- Ensure that site facilities and staff are adequate to meet the demands of clinical trials conducted at the site.
- Review clinical trial protocols and prepare and manage site staff in the conduct of all protocol-related activities.
- Review, approve and implement strategies, policies, and standard operating procedures.
- Attend site initiation meetings, investigator meetings, and other meetings related to clinical research activities.
- Develop, support and comply with annual budget, including billability levels, revenue and expense targets.
- Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system.
- Develop in-service training for site employees.
- Development of proposals in response to RFPs from pharmaceutical and biotech companies.
- Serve as primary contact with the sponsor regarding overall study conduct, timelines, and budget.
- Responsible for allocation of resources to the study including outsourcing and the identification of vendors.
- Development of project documentation e.g. case report forms, regulatory binder development, drug accountability logs, screening and enrollment logs.
- Responsible for tracking and managing the budget allocated to the project and reporting on the overall trial budget.
- Responsible for site selection, initiation, and start-up activities in collaboration with the clinical team.
- Responsible for interim study conduct, including tracking subject recruitment and enrollment, safety issues including SAE tracking, study drug supply, and monitoring report review in collaboration with the clinical study team.
- Identifies areas in which resources or progress are not consistent with the project plan and formulate corrective action plan.
- Communicate up-to-date information regarding study progress to all relevant parties.
- Responsible for study close-out, coordination of data query resolution, and database lock to meet study timelines.
- Development of internal SOPs.
- Oversight of storage of documents, as appropriate, in temporary or long-term storage in accordance with standard procedures.
- Other project management duties as required.
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