Associate Principal Data Manager (Lead Data Manager)
Wokingham, United Kingdom
We’re looking for an Associate Principal Data Manager (Lead Data Manager) to join our team! This is a permanent role to be either office based in Wokingham, UK or home based.
You will be accountable for:
- Coordinating and acting as point of contact for all data management responsibilities for multiple studies when designated as the Lead Data Manager for the Premier Research project team;
- Preparing data management plans, CRF completion guidelines, data management reports and other documents required for preparing and completing databases;
- Reviewing draft protocols and CRFs for potential data collection and representation, database structure or data entry problems, and providing feedback to the project team;
- Reviewing CRFs, data listings, and databases to ensure all captured data follow the rules outlined by the protocol and data management plan;
- Generating paper and electronic queries to appropriate internal or external personnel (investigational sites, vendors, Clinical Research Associates (CRAs), client representatives) to resolve problematic data identified during every aspect of the data management process;
- Reviewing responses to queries for appropriateness and resolving any discrepancies and modifies the database accordingly;
- Reconciling 3rd party data;
- Providing coaching, support and mentoring to less experienced team members;
- Leading in task force groups that impact the team;
- Participating in project costing estimates and proposal review in the business development/change order process;
- Participating in Proposal Defense and Capabilities presentations;
- Tracking CRFs as they are processed through the Data Management department.
You'll also contribute by:
- Quality control reviews of the clinical database (entry screens or data listings) against primary documents (e.g., data management plan, case report forms and queries) for data accuracy, consistency and application of predetermined conventions;
- Developing CRFs, eCRFs, and annotated CRFs;
- Coding medical terms in accordance with coding conventions.
You'll need this background to be considered:
- Educated to Bachelor’s degree level;
- Strong experience in data management within Clinical Research;
- Preferably you will have experience working in a CRO;
- Experience attending and presenting at bid defenses is preferred but not mandatory;
- Understanding and experience with up to date MS Windows Operating Systems and applications and at least one Database Management System (e.g., SAS, DataLabs, Rave, Oracle Clinical, TrialMaster, etc.);
- Attentive to details and able to independently resolve a variety of issues without close supervision;
- Organisation & planning skills;
- Working knowledge of medical terminology;
- Excellent English communication skills (verbal, written & interpersonal).