One of our biotech clients is looking for reinforcement of their Data Management team.
Job description
The Clinical Data Oversight Manager is a functional expert in the field of Clinical Research Data Management (DM), and as such supports the Clinical Study Team (CST) through managing the collection, review and reporting of clinical data and related activities during the planning, set-up, conduct, and close-out of clinical trials.
Responsibilities
Job description
The Clinical Data Oversight Manager is a functional expert in the field of Clinical Research Data Management (DM), and as such supports the Clinical Study Team (CST) through managing the collection, review and reporting of clinical data and related activities during the planning, set-up, conduct, and close-out of clinical trials.
Responsibilities
- Participate in CST meetings as DM representative, and closely interact with Biostatistics, Medical, Clinical Operations and other functional representatives
- Provide data management expertise during protocol development, including for any amendments
- Coordinate DM Contract Research Organization (CRO) Request for Proposal (RfP) selection process, create necessary Purchase Order (PO) Requests and follow up on related Goods Receipt (GR)
- Act as first point of contact for DM CRO counterparts and ensure clinical study data management deliverables within agreed budget and timelines, and with high quality (complying with client processes, ICH-GCP and applicable regulations and guidelines)
- Organize relevant data management oversight meetings and ensure minutes are documented
- Create and maintain Data Management Oversight Plan and ensure proper execution of necessary quality control steps
- Ensure necessary steps are taken to get DM CRO started, and provide further support where needed
- Ensure proper and timely filing of DM-specific documents and files in Trial Master File or other secured dedicated environment
- Actively participate in DM and Biometrics team meetings
- Adhere to relevant policies and procedures and ensure timely completion of relevant training
- Interact with Quality & Compliance to follow up on audit and inspection reports and assigned Corrective Action/Preventive Action plans in timely manner; participate in audits and inspections where needed
- Lead or contribute to Process Improvement initiatives as required
Requirements
- At least 2 to 3 years operational experience in clinical data management
- Broad experience in different clinical trial phases and therapeutic areas is an asset
- Good communication skills
- Fluency in English
- Dutch is an asset