The 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. Also serves as the primary contact with the client to ensure appropriate communications, project budget management, and meeting of timelines.
The Project Manager is responsible for the successful conduct of all client projects, including client satisfaction and operational delivery.
Also responsible for driving process improvements within the project management function that supports larger organizational goals.
- Preparation and implementation of a project plan to ensure quality, 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.
- Reviews and provides input to 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, as necessary
- 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 per project scope of work ,including but not limited to 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, as applicable.
- 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 duties as assigned
Between Corporate New Jersey and New York locations, and other investigators/sponsor sites as needed.
- The position of Project Manager requires at least a Bachelor’s degree, plus a minimum of three (3) years of clinical research experience managing projects of various complexity.
- The position requires 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.