Clinical Research Scientist
On behalf of our client, a global medical devices manufacturer in the orthopedics industry we are currently looking for multiple Clinical Research Scientists (Junior/Professional to Senior level).
Start - July 2020
Contract lengths - 12 months initial contract (potential for 2+ years)
Location - Remote
Contract type - W2 contract including benefits and 2 weeks PTO
The (Senior) Clinical Research Scientist will be responsible to support the development of post-market clinical research strategies of orthopedic devices and execution of the clinical research activities to support global regulatory and post-market surveillance requirements.
- Work closely with cross-functional teams (Clinical, Medical, Regulatory, R&D, Marketing) to support the development of post market clinical evidence generation strategies that consider evidence needs for EU Medical Device Regulations (EU MDR). Facilitate clinical evidence reviews with cross functional team to align on clinical evidence strategies and activities.
- Develop and write high quality reports with minimal supervision. Support development and drafting of clinical study protocols, registry plans, epidemiology studies, informed consents, investigator brochures, and other study materials where needed.
- Review summaries of clinical evidence and PMCF strategies in other areas of the Technical Documentation for accuracy and completeness. This includes the Clinical Evaluation Plan, Clinical Evaluation Report (CEP), Post Market Surveillance Plan and Periodic Safety Update Report (PSUR).
- Maintain strong understanding of evolving post-market evidence requirements under EU Medical Device Regulation.
- Where required, 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.
- Support clinical scientific discussions with internal stakeholders within Clinical, Medical, Regulatory, R&D and Marketing to drive support of the clinical and regulatory strategy and communicate evidence needs.
- Contribute to appropriate interpretation and dissemination of all evidence generated, including abstracts, manuscripts, and Clinical Study Reports (CSR), epidemiology study results and clinical literature.
- Develop a strong understanding of the orthopedic device product portfolio and business needs for clinical evidence to meet regulatory requirements.
- A Bachelor's degree in Biological Science or related discipline, with a minimum of 4 years' experience in the medical device industry or healthcare field is required. Senior positions require at least 8-10 years of experience.
- Advanced technical writing skills is required, with demonstrated experience in writing clinical study protocol /reports strongly preferred.
- Strong project management skills required, with demonstrable track record of success managing multiple projects simultaneously with minimal supervision.
- Ability to communicate effectively and work with teams is required.
- Previous experience developing strategies to generate clinical evidence is strongly preferred.
This is an exciting long-term opportunity with a global leading medical devices manufacturer. If this position is of interest to you please use the "apply" button.
We are looking forward to hearing from you for the (Senior) Clinical Research Scientist role.Sthree US is acting as an Employment Business in relation to this vacancy.