[Hiring] Start Up Specialist @Syneos Health

Role Description

Here at Syneos Health, we are looking for a Study Start Up Specialist, speaking French to work sponsor dedicated. You will have the chance to work in exciting studies with a dynamic Team. The job location will be Home Based in Canada.

As a Key Member of the Clinical Team, you will be Responsible for activities related to study start up and ongoing study document management. You will Act as point of contact for local study teams and external stakeholders.

Job Key Duties and Responsibilities:

• Independently manages multiple country, study and site level deliverables during start-up and maintenance both within the laboratory and external business partners and vendors, when required.
• Plans and develops strategy for start-up activities to ensure successful recruitment and delivery to trial milestones.
• Prepare Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents.
• Support local regulatory in preparing and performing submissions for Health Authorities including follow up until approval. This includes substantial amendments and any other documentation requiring HA submission.
• Prepare and perform submissions for Ethics Committees including follow up until approval (protocol, amendments/IB and any other documents requiring EC submission).
• Collaborates with other internal roles in country feasibility and site selection.
• Collaborates directly with the internal study teams, external site staff, country ethics committees/IRB to ensure tasks and priorities are aligned to the defined study timelines.
• Prepare country Informed Consent Form (ICF) and manage country ICF template.
• Review and approval of Site ICFs.
• Review and approval of Clinical Trial Package (CTP) documentation.
• Update national registries as applicable.
• Ensures that the electronic Trial Master File (eTMF) contains the relevant Clinical Trial Package (CTP) regulatory documents for site activation and ongoing study management.
• When applicable, conduct drug/IMP label review & translation.
• Serves as expert on country regulatory requirements and keeps up to date with evolving regulation in collaboration with Regulatory and legal.
• May support the collection and distribution of documents from / to sites including obtaining insurance certificates.
• May support Health Authority inspection and pre-inspection activities.
• May support audit preparation & Corrective Action / Preventative Action preparation for local related issues.

Qualifications

• Fluent French and English and Bachelor's or Master's degree in Life Sciences or equivalent.
• Min of 3 years experience as a SSU Specialist, including handling of trial start-up activities coordination of trial start-up activities and Health Authority / Ethic Committee submissions.
• Thorough understanding of GCP, ICH Guidelines and Country regulatory environment.
• In depth knowledge and understanding of clinical research processes, regulations and methodology.
• Demonstrated organizational and planning skills and independent decision-making ability.
• Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives.
• Strong organization and time management skills and ability to effectively manage multiple competing priorities.
• Ability of critical thinking and risk analysis.

Benefits

• Competitive remuneration package with excellent benefits.
• Commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organization.
• Opportunity to work within a successful and rewarding environment.

Company Description

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Discover what your 25,000 future colleagues already know:

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself.
• We are continuously building the company we all want to work for and our customers want to work with.