Exciting opportunity to combine academic rigor with industry efficiency. CPC is an academically led CRO who has responded to the demands of a fast-paced clinical research industry and competitive market for over two decades. CPC is on the cutting edge of scientific, clinical and regulatory developments. CPC offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas.
- Relative to the Project Manager position this position will not require as much supervision and oversight
- Work closely with the Head of Research Operations to ensure overall quality and project services, proactive issue resolution and development of systems to standardize and improve project management practices as well as the whole ARO’s efficiency.
- Serve as an Executive Project Manger, mentoring and overseeing other Project Managers within the department, including guidance on what efforts and activities are required to ensure the overall quality of project services and deliverables.
- Serve as a Project Manager and primary point of contact for industry-sponsored clinical trials including international trial as necessary.
- Adhere to local, federal and international regulations, guidelines and CPC Policies, Standard Operating Procedures (SOPs) and Work Instructions (WIs).
- Contribute to process improvement within Research Operations, including but not limited to review and/or development of SOPs, and development and/or implementation of methods to improve quality of sponsor deliverables.
- Assist Business Development with benchmarking for budgets and development of sponsor proposals and service agreements.
- Develop and manage multidisciplinary project team members related to project management activities. Schedule, plan for, and document regularly scheduled project team meetings. Assess project issues, propose resolutions to the project team, CPC executives and/or the Sponsor, and then track implementation of resolution through to completion.
- Define and monitor project scope, timelines and deliverables from project initiation to close out. Assist in study site selection, initiation and monitoring as required by project. Provide drug tracking and disposition as needed as required by project.
- Ensure the overall quality of project services and deliverables.
- Assure qualifications and accurate study regulatory documents for new sites and work with RA/QA on approval for investigational product release.
- Participate in the design, writing and review of all project-related documents including: budgets and proposals, change orders, and study content documents including protocols, case report forms, statistical analysis plans, study reports and monitoring documents.
- Participate in the review, development and testing of study databases.
- Provide status reports on all assigned projects as necessary. Provide timely feedback to the Head of Research Operations on the progress of project assignments.
- Track and request study site and vendor payments.
- Provide necessary updates and reports to the Sponsor as outlined by the contract.
- Supervise and evaluate performance of all staff reporting to this position. Additionally, provide performance feedback to supervisors for all project team members.
- Manage and conduct CPC Core Lab activities as deemed necessary.
- Oversee SAE process and assure execution of safety plans.
- Identify vendors and manage vendor services.
- Additional activities within Research Operations as required.
- A BA/BS in a scientific field (or equivalent knowledge/experience) with a minimum of 5 years of experience in in a clinical research setting required, including a minimum of 3 years of sponsor or CRO clinical research project management experience.
- Mastery of the Project Manager position as demonstrated through successful execution of all aspects sponsor/CRO clinical trial management, as well as the ability to mentor and oversee the activities of other PMs.
- Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials.
- Experience with MS Office including Outlook, Access, Word and Excel.
- Exemplary skills with leading and managing multi-disciplinary teams, as well as mentoring other team members, in a clinical research setting.
- Excellent interpersonal communication skills, organizational skills and a great attention to detail are required. This individual must be able to work as a leader and member of a team and possess good problem solving skills.
- Possess the ability to organize, instruct and supervise staff, while promoting group effort and achievement.
- Ability to manage conflicts and resolve problems effectively.
- Ability and willingness to travel up to 15%.