Clinical Research Scientist
Proclinical is currently seeking a Clinical Research Scientist for its client located in Raynham, MA. Successful candidate will 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.
- Manage, Initiate and Execute timely on strategic plans and deliverables.
- Lead PMCF study start-up, and ongoing oversight.
- Oversee and manage sites participating in PMCF.
- Support Clinical MDR activities & deliverables.
- Work closely with cross-functional teams 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.
- Draft Post-Market Clinical Follow-up 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.
- 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.
- Maintain strong understanding of evolving post-market evidence requirements.
Skills and Requirements:
- BS in Biological/Biomedical Science or related discipline, with 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.
- Experience working in clinical research and/or regulatory affairs in Orthopaedics and/or Sports Medicine is preferred.
- Excellent oral and written communication skills.
- The ability to travel domestically up to 5% 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 Maya Smith at (+1) 267-405-6995 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.
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