Sanofi

The CTSM Team leader is responsible to support the clinical study leadership to execute and deliver on our clinical studies.

The Clinical Project Leader is responsible and accountable for start-up and follow up on Registries in close collaboration with Registry Team and Medical Affairs staff in the countries or locally.

Maintain effective relationship with the end stakeholders medical scientific community within the allocated Global Business Unit and product – with an end objective to develop education and communication content as per requirement

Work closely with Senior director EBM strategic planning and operations, business partners, therapy areas lead, eBuy manager, external vendors

Degree in a Medical, Pharma, scientific discipline or a related Life science degree, with substantial project management or clinical trials and drug development experience.

Strong years of experience in pharmaceuticals, healthcare industry, specifically within innovative pharma. Strong years experience in Competitive Intelligence delivering insights on pipeline products excluding generics and biosimilars, targeted mechanisms of action, modalities, technology platforms and clinical trials activities.

Experience in Clinical Data Management. Good team player and ability to foster a good collaboration within CDM and with clinical study team

Review qualification protocols, reports, and documentation for accuracy, completeness, and compliance. Collaborate with cross-functional teams, including Quality Assurance, and Engineering, to ensure alignment and consistency in qualification practices.

Monitoring CAPA till completion, Management of lateness documentation form, identify the Deviation Owner, Follow-up in case of no response, Identify potential critical and major systemic deviation and escalate as required. Identify Trends during ongoing investigations and as part of retrospective reviews.