Clinical Data Manager
In a new role as Clinical Data Manager, you will help shape a small, growing team in the UK. It will be the perfect environment for your clinical research expertise and your knowledge of Electronic Data Capture (EDC). Better still, you will be operating on a truly global scale and helping us keep our vital clinical data operation securely in-house.
Vertex creates new possibilities in medicine. Our scientists and collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, epilepsy and other life-threatening diseases. As the U.K-based subsidiary of Vertex Inc. Vertex Europe’s scientists work in an environment, where chemists, biologists, structural biologist and computational chemists focus together on cancer and inflammatory diseases. In our state-of-the art research facility in Oxfordshire, our world class teams are tackling the most ambitious projects in the industry through collaboration of the wider organisation.
Part of a small UK team working alongside a larger US group, you will be an individual contributor performing complex data management tasks independently and managing external vendors on assigned studies. Besides reviewing clinical study protocols, you will develop eCRFs for new and complex projects. We will look to you to, conduct the cross-functional Data Review and develop the Data Management study timeline.
Another part of your brief will involve overseeing vendor DM activities, including timeliness and quality of deliverables. You will also review statistical tables and listings and Clinical Study Reports, ensure study compliance with SOPs and regulations, and develop study-specific training. In addition, you will plan and oversee development of Data Management Plans, Data Entry Guidelines, CRF Completion Guidelines, Data Review Guidelines, and eCRF help text; and plan, perform and oversee development of specifications for eCRFs, edit checks, electronic data handling, and manual review.
The execution of User Acceptance Testing will be down to you, and you will prepare and deliver presentations at internal and external meetings.
Together with a life science degree or equivalent, you will have experience of working with another pharmaceutical, biotech company or in a CRO. You will certainly have a keen knowledge of Clinical Data Management and EDC. Beyond this, you should have well-developed communication skills to liaise with various stakeholders across the business. A self-starter, you’ll be happy to work individually in a challenging environment as well as part of a global team. Confidence and a broad cultural outlook will also be key, as you will be inputting into local and global meetings. Ideally, you’ll be familiar with InForm.
In return, you can look forward to an impressive benefits package that includes 28 days’ holiday, employee stock purchase plan and group stakeholder pension. And as we, more than anyone, know the importance of staying healthy, you will also be eligible for private medical, dental and optical insurance as well as life insurance. Plus you can take advantage of our cycle scheme, work place nursery and gym membership.
Deadline: 11 June 2012