Site Activation Specialist

Site Activation Specialist

Location: Montrouge, 1, FranceJob ID:

Job Responsibilities

• Responsible for quality deliverables at the country level; follows project requirements and applicable country rules with moderate oversight from the SSU Country Manager. Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in the agreed SSU tracking system in real time; if forecasted timelines are not reached: investigates and provides clear rationale for delays, provides support on a contingency plan to mitigate impact, and escalates the issue as soon as identified.
• Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
• Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.
• Supports continuous improvement of quality in all Site Start‑Up (SSU) components at the country level where assigned (submissions, essential document collection, communication to Competent Authorities and ECs, etc.).
• Ensures all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
• Responsible for the Local Submissions Specialist – follows the project direction provided by the designated country start‑up advisor (CSA) and SAM, may serve as a point of contact for the PM/SAM during start‑up on allocated projects, compiles and reviews essential document packages for site activation, prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required, prepares ongoing submissions, amendments and periodic notifications as needed within the country, and includes safety notifications as required by local rules.
• May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues. Oversees site activation end‑to‑end process at country/site level.
• Country Start‑Up Advisor – acts as Subject Matter Advisor for in‑country performance within the Site Start‑Up, supports country‑level intelligence on start‑up (SU) and clinical trial regulatory (CTR), ensures that local country regulatory intelligence pertaining to the activities of the local SU and CTR team is maintained on the central repository, provides input in local SOPs and WI, supports the creation of internal training materials on local legislation requirements and assists in EC or CA issue resolution at the country level.
• Local Site ID and Feasibility Support – provides support with site selection lead and PM/SAM to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial.
• Local Investigator Contract and Budget Negotiator – provides support to SAM to agree on country template contract and budget, produces site‑specific contracts from country template, provides support in submissions for proposed contract and budget for site, negotiates budget and contract with site via Site Contracts Service Centre and SAM with Sponsor until resolution of issues and contract execution; performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.

Qualifications

• Bachelor’s Degree.
• Detailed understanding of clinical trial process across Phases II–IV and ICH GCP.
• Ability to understand clinical protocols and associated study specifications.
• Detailed understanding of clinical trial start‑up processes.
• Ability to manage external vendors to contract effectively.
• Strong organizational skills with ability to handle multiple tasks effectively.
• Strong written and verbal communication and interpersonal skills.
• Ability to manage multiple project budgets with increased complexity and value.
• Quality‑driven in all managed activities.
• Good problem‑solving skills.
• Good negotiating skills.
• Demonstrated ability to work independently as well as part of a team.

Additional Information

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. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.