Sr SSU & Regulatory Specialist - Sponsor dedicated - Paris Office

Description

Here at Syneos Health, we are looking for a Senior Start Up & Regulatory Specialist to work sponsor dedicated. You will have the chance to work in exciting studies with a dynamic Team. The job location will be Client Based at Rueil Malmaison / 50% Home Based.

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

Qualifications:

• 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

Are you interested?

If you are interested in this role and you believe you would be the right fit, we would be more than happy to hear from you. You can apply online.

To find out more about our company and search and apply for other open jobs please visit our website https://www.syneoshealth.com/ 

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About us:

Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 30,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform.

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.