Company: PRA Health Sciences
Closing Date: 25 Dec 16
Type: Full Time
Salary (£): Competitive
Position: Study Data Manager Contract: Permanent PRA HS Model: Outsourced to client Location: Home-based Salary: Competitive Benefits: Competitive
Study Manager Data
As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs.
At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.
At PRA, borders do not create boundaries. PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals. Our growing workforce is comprised of over 10,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community.
For more information please see our website; www.prahs.com
As a Study Data Manager at PRA, you will be Joining a well-established yet expanding team fully outsourced to one of our global pharmaceutical clients. You will be responsible for ensuring overall successful development, implementation and maintenance of the Data Management Plan of phase 1-4 clinical trials on either a global or regional level.
Reporting to the Senior Manager of Global Data Management and working as part of the global Study Data Management team, you will have oversight of the data management project deliverables and serve as the leader for the Study Management Team. You will manage and track key study metrics to ensure adherence to data management milestones.
Key responsibilities include:
* Developing, implementing and maintaining the Data Management Plan
* Execution of data validation plans
* Reporting on the status of projects and tasks
* Proposing solutions to process and technical issues
* Ensuring timely generation and tracking of data queries
* Interacting with the sites, CRA’s and Lead CDC’s
* Reconciliation of external data
We are seeking a Life Science degree qualified clinical data management industry specialist who has excellent written and oral communication skills.
With a Life Sciences degree, you will be proficient in the use of Clinical Trial Database systems, including Medidata, as well as proven experience as a Lead Data Manager (Study Data Manager) on assigned studies. Experience of setup through to maintenance and to database lock is essential, along with experience of representing the data management team on study calls.
500 South Oak Way
|Tel:||+44 (118) 918 1000|
|Fax:||+44 (118) 918 1001|
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