Senior Clinical Data Manager

Contenu de l'offre Senior Clinical Data Manager chez VENN LIFE SCIENCES

CDI

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 mission is to deliver high quality drug and device development consulting and services to our customers across their full product development life cycle. 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 looking for an experienced Senior Data Manager to join the Venn team in our office in Paris.

The successful candidate will be 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.

If you are seeking a rewarding and challenging career this could be the perfect opportunity for you.

Responsibilities:

Serve as the primary contact for the sponsor, internal and external team members and partners to establish, align and confirm data management activities and deliverables for the assigned trial. Serve as the Data-management representative on assigned project teams, providing proactive support to Project Management and develop efficient work plans and timelines for data-management activities and deliverables. Manage end to end delivery of data management services for single/multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction. Review project budgets and staffing projections for data management activities. Ensure continuous, accurate and transparent reporting of data management activities and escalation and documentation of issues (e.g. quality, timelines, deliverables, budgets). 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 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. Participate in the training and mentoring of junior employees and promote teamwork within the data management team. Contribute to business development e.g. identifying business opportunities, playing a supporting role in Requests for Proposals preparations, input to and review budgets etc. Ensure high level of customer satisfaction by focusing on efficiency and results and meeting customer expectations on assigned work activities.

Your Profile

Qualifications & Experience:

Data Manager or computer programming background (BAC + 2 to BAC + 5). Strong knowledge of SAS programming and CDISC standards. At least 7 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. Experience leading and managing teams.

Skills:

Results and quality oriented with the ability to multi-task, skill in establishing priorities, managing workloads and meeting strict deadlines. Ability to anticipate potential issues and problems that may arise and proactively identify ways to resolve/mitigate. Ability to be flexible and to adapt and work effectively with a variety of situations or individuals. Team worker with excellent customer service and interpersonal skills, ability to communicate effectively and form positive relationships at all levels in and outside the company. Demonstrates excellent judgement and decision-making capability. Professional who is experienced and dependable with discretion, enthusiasm and a positive attitude. Excellent written and verbal communication skills including excellent command of English.

Job Types: Full-time, Permanent

Experience:

Clinical Data Management: 7 years (Preferred)