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

DESCRIPTION OF THE COMPANY

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
.

Tissium’s technology
is based on research and
intellectual property
from the laboratories of
Professor Robert Langer (MIT)and
Professor Jeffrey M. Karp (Brigham and Women's Hospital), who co-founded the company with
Christophe Bancel (CEO)and
Maria Pereira (Deputy CEO & Chief Innovation Officer).

We are developing
polymers for atraumatic tissue repair
in various applications. Today, these
polymers
are used for
sutureless nerve repair
,
hernia repair
, and
cardiovascular sealing
.

Since our inception, we have raised a total of
170 million euros
. Our latest
fundraising round
, which concluded in
April 2023
, resulted in
50 million euros in additional funding
. This infusion of capital provides us with the necessary resources to finance the
commercialization of our first products
.

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.).

Clinical Operations Support

• 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.

Field Clinical Product Support

• 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 Clinicial 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…