Study Startup Specialist (4-5 Months)

Study Start-up Specialist (4 Months) - Interim 

Brussels

Clinical Research, Study startup, site relationship, CPM, Clinical Project Manager, Clinical Research Associate, CRA, Study Start-up Specialist, Pharma, Pharmaceutical, Medical device, Oncology, Study, Biotech

My client is a leading Pharmaceutical company specialising committed to improving access to healthcare and supporting the people they serve throughout the continuum of care. They are currently seeking a Study Start-up Specialist for an interim position (4) months to join their offices near Belgium.

The successful Study Start-up Specialist will have
. Degree level education in Health Sciences or a relevant discipline and/or considerable knowledge in previous start-up roles
. Experience in clinical study protocol development and ethical submissions
. Excellent communication skills for ongoing communication with team
. Advanced proficiency in English, both verbal and written. Speaking Dutch is an advantage.

The role will require you to
1.Coordinate guide and assist with all start up activities prior to site activation, including but not limited to:
.Site Informed Consent Form (ICF) localization and guidance in line with regulatory/health authority requirements.
.Ethics Committee information, meeting dates & costs.
.Ethics applications & associated online systems.
.Ethics & Governance submission processes.
.Clinical Trial Health Authority application and regulatory submission process.
.Contracts & Indemnity request process.
.For global studies, localize global Informed Consent Form (ICF) with country requirements.
.Local sample application and permit submission processes.
.Maintain up to date knowledge, ensure adherence and compliance with local regulatory requirements and associated documentation.
.Review, analyze and collate metrics to ensure processes are in place that drive efficiency and reduction of timelines across start up and contracts negotiation.
.Ensure all start up information & requirements are kept up to date in a central repository for both global and local Study teams.
.Assist with label preparation and approval (local label representative) for studies in collaboration with local regulatory department.
.Track metrics and study start-up timelines to identify trends and opportunities for improvement.

2.Relationship management:
.Liaise and collaborate with relevant authorities/bodies to further enhance clinical trial processes, government policies/laws, via innovative approaches.
.Maintain currency and awareness of changes in Start Up processes across government, hospital & industry & liaise with stakeholders to resolve any SSU issues.
.Proactively respond to information survey requests by government/industry bodies.
.Provide continuous and proactive communication with ECs/hospital administration/industry bodies to obtain accurate and up to date information on clinical trial status and activities.
.Maintain communication with local legal/regulatory/clinical operation to ensure input is sought and all internal/external requirements are met.
.Provide guidance to CSMs and CSS on regulatory/ethics, track & drive site activations by regular review and monitoring status of submissions/activations.
.In collaboration with vendor management and procurement, provide input as required into vendor identification, selection, and RFI/RFP process.
.Liaise and share best practices with other SSU within the region/organization.

3.New Site Identification:
.Assist with identification and tracking of new sites in collaboration with CSMs.
.Perform/coordinate site level feasibility activities including evaluation of patient
population and final site selection.

4.Recruitment:
.Provide expertise and guidance to Global and/or Local Study Team (LST) for identification, creation and implementation of specific recruitment/retention tactics & contingency planning.
.Initiate patient recruitment meetings with CSM and advise on study-specific recruitment & retention needs.
.Develop innovative patient recruitment/retention practices and share concepts with vendors as needed.
.Provide justification/recommendation of site closure in collaboration with CSM.
.Provide reports to local study teams on overall site performance as required.

5.Contracts/Budget:
.Negotiate contracts and study budgets with sites during the study start-up phase to ensure finalization.
.Provide local fee structures and budgetary advice as required and ensure compliance to Fair Market Value (FMV) in the country.
.Collaborate with CSMs to maintain data to ensure FMV
.Liaise with management/Country Study Managers (CSM) to implement budget cost containment and implement contingencies as required.

The ideal candidate
You're someone who wants to influence your own development. You're looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

Get in touch

If you think you meet the criteria for this role, please apply to this post or forward your CV to me directly at (see below)

Amoria Bond operates as an employment agency and employment business. No terminology in this advert is intended to discriminate on the grounds of age or experience, and we confirm that we are happy to accept applications from persons of any age or experience for this role.