Field Clinical Product & Research Specialist (FCPRS) H​/F​/X

Job Title

Tissium is a mission-driven medical device company founded in 2013, headquartered in Paris, with a production facility in Roncq (near Lille) and an office in Boston. We are dedicated to creating a new era of body repair by leveraging our biopolymer platform to develop innovative solutions in surgery for a positive impact on patients' lives.

The FCPRS is responsible for the successful execution of clinical trials by supporting site management and monitoring activities. Ensure assigned clinical studies comply with regulatory standards and protocols by conducting site visits, verifying data accuracy, and safeguarding patient rights. Typically works on studies with moderate to high complexity (in terms of design, location, regulatory requirements, etc.). Proactively identifies and resolves clinical site issues and participates in process improvement initiatives as required.

Contributes to the development of clinical development plans, and other company initiatives as required. Additionally, FCPRS may be requested to support field-based clinical support by providing information and training to customers in the use of specific products in a clinical setting (e.g., operating room, outpatient clinic, etc.).

• Responsible for site management and monitoring of assigned clinical study(ies). Collaborate with Study Management and other clinical operations staff to perform site management and field monitoring activities:
• Establish and maintain excellent working relationships with external stakeholders such as Investigators, Study Coordinators and other site staff; and internal stakeholders to meet recruitment targets and to deliver high-quality data on time.
• Ensure that all Adverse Events (AE), Serious Adverse Events (SAEs) and Product Quality Complaints are reported within the required reporting timelines and documented as appropriate.
• Maintain and update trial management systems.
• This individual will be required to perform field monitoring independently, including but not limited to qualifying site assessments, and initiation, interim and closeout visits.
• Complete monitoring reports, follow-up letters etc. ensuring compliance to company SOPs and timelines.
• Data monitoring activities, including on-site and remote review of study data for accuracy, integrity, and completeness
• Build a collaborative partnership with CRAs and support as needed.
• Assist the study team in planning clinical supplies and in particular, the Investigational Product. Ensuring that the product is available for the sites to support study enrollment.
• Provide site training (Protocol, Amendment, GCP, etc.), as required.
• Support the collection of essential documents and the maintenance of the TMF, as required.

• Serves as the primary resource for clinical support in the areas of patient selection, basic troubleshooting, device utilization, and patient follow-up for company products.
• Provide on-site clinical, technical, and educational support, guiding medical staff through use of commercially available medical devices, and troubleshooting products in operating rooms or other medical facilities.
• Provides external staff training, and other product-related specifications, as requested.
• Maintains a working knowledge of Company products, competitive devices, and new or competitive techniques used in surgery.
• Performs other related duties as qualifications and training allows.

This role will report to the VP Clinical Affairs.

• You are to work independently and collaboratively within a team environment.
• You have excellent interpersonal, time management, and oral and written communication skills.
• You have strong written and oral communication skills and experience mentoring/coaching and providing training is preferred.
• You are able to collaborate with all levels of management in a cross-functional team environment is required.
• You love to travel to support customer and study meetings is a must (up to 60%); for domestic, trans-border and international.

• At a minimum, completion of an undergraduate degree (e.g. Life Science, Nursing, Medicine, Biomedical Engineering, etc.) is required. Clinical Research Certification is an asset. Registered Nurse (RN certification) is a strong asset.
• A minimum of 8+ years of related job experience is required for this position.
• At least 5+ years of relevant experience within medical devices, surgery, and operating room support.
• At least 5+ years of field monitoring and site management performing pre-study visits, initiation, interim, and close out visits.
• Demonstrated working knowledge of ICH-GCP and FDA regulations.
• Must have experience working with patients preferably in a clinical environment.
• Proficient with MS Office and electronic databases (e.g., CTMS, IRT, eTMF).

• Act with a sense of urgency:
  Align stakeholders around critical milestones and drive timely execution.
• Embrace calculated risk-taking:
  Take…