Senior Data Manager
Venn Life Sciences is an Integrated Drug Development Partner offering a unique combination of drug development expertise and clinical trial design and management. This enables us to create, plan and execute drug and medical device development programs effectively and seamlessly for our clients. We have dedicated operations in Ireland, France, Germany, the Netherlands, the UK, the US, and Europe-wide representation.“Our vision is to deliver results of the highest quality to our global sponsors on time and within budget. We do this through developing our staff to be world class in their fields and forming real, lasting relationships with our clients.“We are currently seeking a Senior Data Manager to join our team. The successful candidate will have the opportunity to work from our Paris office (or one of our European offices and/or home-working).If you are seeking a rewarding and challenging career this could be the perfect opportunity for you.
This role is responsible for data management activities for clinical interventional or non-interventional studies ensuring high quality, timely and cost-effective delivery of the data management elements of projects.
- Liaise between Venn Life Sciences, the sponsor and other internal and external partners to establish, align and confirm data management expectations for the assigned trial.
- Serve as the Data-management representative on assigned project teams, providing proactive support to Project Management for preparing efficient work plans and timelines for data-management activities and deliverables, and data-management input into other departmental deliverables.
- Ensure continuous, accurate and transparent reporting of data management activities
- Participate in internal and external project/team meetings
- Conduct DM activities:
- Prepare Data Management Plan
- Lead the CRF and database design activities, in collaboration with other internal and external partners (PM, CRA, statisticians, medical experts)
- Prepare clinical data management documents (Annotated CRF, data-entry guidelines/eCRF user guide, Edit Checks plan, Coding conventions, Deviation list, Data Review plan, Data review minutes) ensuring appropriate quality, content and compliance with regulatory guidelines and company/Sponsor’s SOPs.
- Program, test or validate the Edit Checks programs using various EDC systems
- Program specific data listings, patient profiles and deviations listings using SAS
- Query management
- SAE reconciliation
- Ensure the automatic coding and first manual coding of medical data (desirable)
- Prepare, participate and write the minutes of the Blind Review Meeting
- Prepare and validate submission datasets and documentation for regulatory submissions (SDTM)
- Participate in the writing and updating of data-management SOPs, forms and templates
The successful candidate will have:
- Data Manager or computer programming background (BAC + 2 to BAC + 5);
- Strong knowledge of SAS programming and CDISC standards
- Previous experience (5 to 10 years) in the practice of Clinical Data Management and programming related to database management in a CRO or bio/pharmaceutical setting with experience in all the aspects of data-management activities for a clinical trial (including database design using eCRF, programming and data-cleaning)
- Knowledge of current regulatory regulations, GCP, ICH guidelines in clinical trials, 21-CFR part 11 and other relevant regulatory requirements
- Good organizational and interpersonal skills with the ability to work diligently, accurately and under pressure, alone and/or as part of a team
- Excellent time management skills
- Ability to multi-task, skill in establishing priorities and managing workloads
- Ability to establish and maintain effective working relationships with co-workers, managers and clients
- Excellent writing and verbal communication skills including fluency in English (additional language skills desirable)
How to apply: Please forward your CV (in English) by email to Manon Sauvage, email@example.comWe do not require the services of agencies for this role.