Clinical Research Project Manager
Proclinical is currently recruiting for a Clinical Research Project Manager for our client located in West Chester, PA. Successful candidate will work closely with cross-functional teams (Clinical, Medical, Regulatory, R&D, Marketing) to develop post market evidence generation strategies that consider global evidence needs.
- Maintain strong understanding of evolving post-market evidence requirements (i.e. FDA and EU Medical Device Regulation).
- Develop and draft Post-market Clinical Follow-up (PMCF) plans, clinical study protocols, registry plans, informed consents, investigator brochures, and other study materials with minimal supervision.
- 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.
- Draft Post-Market Clinical Follow-up (PMCF) Reports and study reports with minimal supervision for assigned studies to include any annual reports, study close out reports as well as clinical sections for regulatory submissions.
- Support clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy and communicate evidence.
- Contribute to appropriate interpretation and dissemination of all evidence generated, including abstracts, manuscripts, and Clinical Study Reports (CSR).
- Ensure study registration requirements are met (i.e. clinicaltrials.gov).
- Develop a strong understanding of the orthopedic device product portfolio and business needs for clinical evidence to meet regulatory requirements.
- 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.
Skills and Requirements:
- A Bachelor's degree in Biological 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.
- Demonstrable track record of success managing multiple projects simultaneously with minimal supervision is required.
- Ability to communicate effectively and work with teams is required.
- Previous experience developing strategies to generate clinical evidence is strongly preferred.
- Understanding of Good Clinical Practices is required.
- Understanding and application of US and EU regulations and standards applied to medical device clinical research is preferred
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.