Clinical Data Managers read on
Fantastic Permanent Job with Leading Pharmaceutical Company
Pharmaceutical Company based near Oxford
Broad and challenging leadership role for a capable Lead Clinical Data Manager who has been involved with projects from database design to reporting and worked with global stakeholders to enable prompt analysis and decision making. Our client is an employer of choice, a global pharmaceutical company which is creating a buzz and achieving breaking new ground in^medical intervention in key disease areas. In this newly created additional headcount role as Clinical Data Manager, you will help shape a 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 client to keep a vital clinical data operation securely in-house.
Our client 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 UK-is a based subsidiary of our clients, our client European scientist's 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.
Essential Skills & Qualification
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.
Our client is an Equal Employment Opportunity/Affirmative Action employer. All employment decisions are made without regard to race, sex, national origin, colour, religion, age, disability, veteran status or any other status protected by federal, state or local law.
Employer: Pharmaceutical Company
Hours: Full time, office based
Location: Office Based, M40/A34 access
Data Manager, Coding, Clinical Data Management,RDE, EDC, eCRF, SOPs, Compliance, UAT, Inform
Assigned Consultant: Call Ann Maloney at CSL on 01932 234689
Please fee free to call for a detailed Job Description or additional information
Closing Date: 24th August 2012