Clinical Project Manager
Proclinical is currently recruiting for a Clinical Project Manager for a global biopharmaceutical company located in Philadelphia, PA. As the Clinical Project Manager, you will work as an expert in your therapy area, working independently with vendors/partners and then supported as necessary based on an individual development plan.
- Review and provide input to study protocols.
- Interact with and day to day management of vendors including supporting Head of Clinical Operations with vendor budget oversight.
- Create/Review patient consent forms and provide relevant opinion.
- Review CTAs with Vendors and sites, and provide relevant feedback.
- Have responsibility for oversight and delivery of components of clinical trials and data generation.
- Serve as a close partner to the study physicians, co-ordinating the activity of a research team and holding full accountability for projects, often with global impact.
- The overall efficient day-to-day clinical trial management of studies.
- Liaise with vendors for RFIs and RFPs, and involvement in vendor selection activities.
- Oversight of various vendors activities.
- Manage contract requirements.
- Perform on site visits as required to ensure corporate deliverables.
- Occasional interim monitoring visits, including site qualification, initiation and close-out, including the source data verification of CRFs and Data clarification forms as stipulated.
- If required review the preparation and publication of data, reports and information, ensuring that these meet legislative, contractual and ethical requirements.
- To maintain Project documents in accordance with ICH-GCP and company SOPs and support the transition from paper to eTMF.
- Develop and update study plans and documents, including the Project Plan, Monitoring Plan, Deviation Plan.
- Support the review and development of department SOPs in conjunction with the Head of US clinical operations.
- Support the hiring and mentorship of other members of the Clinical Operations team, for example CRAs or CTAs.
- Review of site monitoring reports when as required.
- Provide site study training and internal training to the clinical ops team as required.
Skills and Requirements:
- Bachelor's degree (BSc, BA or RN equivalent) in biological or science-related field is essential
- 7+ years clinical trial experience with 2+ years' experience in a senior or lead role.
- Strong clinical study experience in cell or advanced therapy.
- Previous experience of site monitoring in early phase oncology studies ideally in melanoma or NSCLC.
- Excellent collaboration and communication skills.
- Adept at partnering with a diverse team and delivering results through taking ownership of key programme components.
- Strong clinical, technical or disease area expertise.
- ICH GCP trained.
- Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel and service providers.
- Thorough knowledge of ICH-GCP guidelines and UK legislation.
- Excellent communication, interpersonal and organisational skills.
- Effective problem-solving skills. Attention to detail and timelines.
- Computer literacy, proficiency in Microsoft Office. Ability to work independently and to effectively prioritise tasks.
If you are having difficulty in applying or if you have any questions, please contact Paige Sanderson at (+1) 646-367-2618 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.