Clinical Research Post Market PM
Proclinical is currently recruiting for a Clinical Research Post Market PM with our client located in Raynham, MA, West Chester, PA, and Warsaw, IN. Successful candidate will be responsible for the development of post-market clinical research strategies of orthopedic devices to support global regulatory and post-market surveillance requirements.
- Manage, Initiate and Execute timely on strategic plans and deliverables for Mitek Post-market Clinical Follow-up (PMCF)
- Develop and draft Post-market Clinical Follow-up plans, clinical study protocols, registry plans, informed consents, investigator brochures, and other study materials with minimal supervision.
- Lead PMCF study start-up, and ongoing oversight
- Oversee and manage sites participating in PMCF
- Support Clinical MDR activities & deliverables
- Conduct Fair Market Value Analysis for contracts
- Complete Needs Assessment for contracts
- Build and maintain project management tools for programs
- Work closely with cross-functional teams (Clinical, Medical, Regulatory, R&D, Marketing) to develop post market evidence generation strategies that consider global evidence needs and product lifecycle.
- Foster relationships with surgeons, hospitals and research teams to gain input into study design, evaluate study feasibility, and identify sites for study execution or data collection.
- Develop strong collaborative relationships with the study core team and others to ensure study progress for assigned projects and that issues are identified and communicated to leaders.
- Partner with the Contracts and Payments team to ensure timely execution of all study agreements and corresponding payments for achieved milestones and deliverables.
- Keep management informed of key developments and issues that impact clinical strategy and portfolio management.
- Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders.
- Supports budget development and management of clinical projects
- Responsible for complying with all company procedures
- Maintain strong understanding of evolving post-market evidence requirements (i.e. FDA and EU Medical Device Regulation).
Skills and Requirements:
- Bachelor's degree in Biological/Biomedical Science or related discipline, with a minimum of 4 years related scientific, technical, or clinical research experience.
- Previous experience in the Medical Device industry is required.
- Advanced technical writing skills is required.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Samantha Reader at (+1) 267-983-0134 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
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.