Clinical Team Lead Fspx

il y a 1 jour

RueilMalmaison, France Labcorp Temps plein

**Clinical Team Lead FSPx - France**

**Location: hybrid model within Parisian region**

Get ready to redefine what's possible and discover your extraordinary potential at Labcorp Drug Development. Here, you'll have the opportunity to personally advance healthcare and make a difference in peoples' lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you'll be empowered to own your career journey with mentoring, training and personalized development planning.

Join Labcorp Join the Pursuit

Dedicated to one of our Sponsor, you will be responsible for study oversight and delivery management (time, budget, quality) at country level from start-up to closure and will serve as the main point of contact at country level for internal and external stakeholders.

**Responsibilities**:

- Coordinates proposal and validation of country study targets and develop patient recruitment strategy & risk mitigation.
- Leads problem solving and resolution
- Assessment and set up of vendors during study start up period (locally) + familiar with translating and preparing documents for regulatory submissions (ICF, synopsis )
- Investigator Meeting participation and preparation
- Ensures CTMS and eTMF accuracy
- Validation of study related materials (i.e. protocol, ICF, patient material) and preparation of country specific documents (e.g. amendments)
- Prepares materials for Site Initiation Visits
- Reviews Site Monitoring visit reports
- Coordination of database locks and query follow up and ensures timelines are met
- Ensure inspection readiness of assigned trials within country
- Coordinates, develops and writes CAPA and ensures implementation for audit findings.
- Reviewing and approving payments
- Management of Site relationships (includes CRO related issues)

**Qualifications**:

- Excellent understanding of GCP, ICH Guidelines and Country regulatory environment
- In depth knowledge of clinical research processes, regulations and methodology
- High organizational and planning skills as well as independent decision-making ability
- Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives
- Critical thinking and risk analysis
- Strong communication skills with a strong customer focus, able to manage both internal and external clients at all organizational levels
- Strong experience in leading clinical projects and operational management of a CRA team

We look forward to hearing from you

**Did you know?**

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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