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Associate Clinical Trial Manager - VIE contract (W/M)

date posted 09/26/2021
contract type Full time
job id R2610756
location Ghent, Belgium

iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.

PLEASE NOTEthat since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.

PLEASE NOTEthat applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide.

Therefore, only applications that are submitted in English will be considered.Please make sure to apply with your personal email address

At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our employees, patients and customers.

We are looking for:AssociateClinical Trial Manager- VIE Contract (W/M)

Target start date: 01/01/2022

The Clinical and Exploratory Pharmacology (CEP) Associate Clinical Trial Manager VIE (ACTM) is responsible for the overall operational planning and activities for the implementation and conduct of clinical exploratory pharmacology clinical trials in compliance with ICH (International Conference on Harmonization), GCP’s ( Good clinical practices), SOPs (Standard Operating Procedures) local requirements, internal/departmental guidelines, and established timelines. The ACTM is involved in the operational planning and scientific conduct of the clinical trial and acts as the leader of operational disciplines (Clinical Trial Team (CTT) to guarantee release of homogeneous high-quality clinical data in close collaboration with the CEP Data Manager (DM) and Clinical Study Director (CSD).

The VIE may manage studies at the product level (if applicable), can be involved in field monitoring activities of his/her own studies according to workload/need and/or manages local monitoring or outsourced monitoring. The VIE may also participate in intra or inter-department Working Groups.

As an Associate Clinical Trial Manager VIE you will:

Provide management and oversight of clinical trials (which may include complex, multiple center and multinational proof-of-concept studies) to ensure progress according to study timelines:

Lead the Clinical Trial Team (CTT) including representatives of all operational disciplines involved in the conduct of trial

Manage the study according to GCPs and local and/or national regulations, with responsibilities on product and project level.

Collaborate with team members on a day-to-day basis; in particular, build a strong collaboration with the study Data Manager (DM) and the Clinical Study Director (CSD).

• Anticipate bottlenecks in all steps of the study and development/implementation of counteractive measures.

• Solve or coordinate the resolution of issues during conduct of the trial.

• Develop and review specific study-related documents.

• Develop and coordinate the study budget, including invoice validation.

• Contribute to contract process.

• Manage investigational product supplies (ordering, packaging, and shipment).

• Participate in and contribute to internal audits, if applicable.

• Serve as main contact for clinical sites and other outsourced activities.

• Manage local MT (CSUs) when applicable.

• Manage outsourced centralized activities when applicable (Central Lab).

• May perform studies following some Phase 2-3 processes when applicable (multicenter-multicountry Phase 2a trials).

• Collect, synthesize, report, file and prepare archiving for clinical trial activities.

• Manage CRO/study sites.

• Escalate quality issues and delays in deliverables, propose solutions, request and ensure follow-up actions.

• Assess CRO performance by completing CRO post services assessments.

• Conduct yearly CRO assessment, if applicable.

• Manage outsourced/sub-contracted monitoring activities, when applicable.

• Lead study-specific training.

• Manage performance of monitors.

• Review and approve all visit reports.

• Conduct field monitoring activities, if required:

• Set-up and manage site visits (Site Initiation Visit, Interim Monitoring Visits, Closure Visit) including in-house preparation such as data listings review.

• Attend site visits as primary or co-monitor (e.g. when mentoring Associate CTMs)

• Conduct source data validation and other monitoring activities (according to the study-specific Monitoring Plan, if applicable).

• Use eCRF Electronic Case Report Forms tool for ongoing data review and query generation.

• Regularly review and reconcile the Investigator Study File, Investigational Product accountability and biological sample management.

• Report visit progress/findings to CSD and other relevant members of the CTT and Site manager

• If applicable, review visit reports.

• Participate to the mentoring and training/coaching of Associate CTMs, apprentices or trainees:

• Utilize department mentoring program.

• Track mentoring/training progress by meeting with mentee on regular basis.

• Participate in intra or inter-department Working Groups, if applicable:

• Propose and implement process improvements.

• Participate in development/improvement of guidance documents.

•Other leadership activities:

May serve as internal consultant for specific departmental activities

May serve as Project leader for the department or external to the department: be the referent for a specific compound and maintain accurate documentation available for the department, participate in Project Team meetings, if applicable

Key “MUST HAVE” competencies, skills & experiences

Master’s Degree in relevant field: bio-medical or bio-pharmaceutical area

At least 1 year of laboratory or medical experience or clinical operational experience at a Clinical

Research Organization or Pharmaceutical company

Previous experience with medical terminology (basic knowledge in medicine is preferred, including laboratory procedures/techniques and biological knowledge) and GCP/ICH Guidelines.

General understanding of R&D processes including the principals of study design and execution.

Capability of interacting effectively with scientists and managers from various disciplines on an international basis.

Ability to serve as internal consultant on assigned area and liaise with external organizations on projects.

Good interpersonal and communication skills (verbal and written).

Self-motivation, flexibility, attention to detail and organizational skills, goal oriented.

Ability to build optimal collaboration within the company and with external partners.

Ability to work in a team environment.

Project Management skills.

Experience with various computer systems/database; a willingness to learn new systems/databases.

Ability to prioritize activities.

Results-driven in terms of timelines and quality

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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