Opportunity for Assistant Data Manager, Cardiac Safety Services in Quintiles

Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our network of 23,000 engaged professionals in 60 countries around the globe works with an unwavering commitment to patients, safety and ethics — ensuring a higher level of healthcare for people. For our biopharmaceutical customers, we help them navigate risk and seize opportunities in an environment where change is constant.
Quintiles is consistently cited as the most favored contract research organization (CRO) in independent surveys of the bio pharma industry and was recently named “2009 CRO of the Year” by the prestigious SCRIP Awards.

Post: Assistant Data Manager, Cardiac Safety Services-1418270

Job Description
PURPOSE
Manage cross-functional quality in Cardiac Safety Services. Serve as a Data Team Lead to the team in the area of Data Management.

RESPONSIBILITIES
• Assist in planning and development of long term strategy for cross functional improvement and awareness of quality issues
• Motivate employees for a clear focus on quality and manage comprehensive quality control procedures.
• Manage DM customer relationship for DM project team including active participation in DM customer negotiation on timeline, budgetary and other issues (with guidance).
• Develop good communication and working relationships across the teams.
• Serve as a Data Team Lead and the main point of contact for various projects as and when required.
• Attend study kick off meetings and internal/sponsor audits for assigned studies.
• Manage the allocated project(s) with control and oversight of day-to-day data flow.
• With minimal guidance, manage project timelines and quality issues, determine resource needs, and identify and justify out of scope areas.
• Confirm there are no interruptions in data, no flaws in the software, and minimal human error. Take corrective action as and when necessary to fix any above mentioned problems.
• Report to the Data Manager or designee on the quality of data collection and any site issues. Apprise them of the status of each project.
• Ensure that all the deliverables are of expected quality standards and meet customer expectations.
• Collaborate with the Clinical Data Management personnel for project timelines, delivery of quality data and frequent project update teleconferences.
• Manage delivery of projects through full data management process life-cycle.
• Manage the development and implementation of new technology / database revisions.
• Ensure that at the end of the study, all data clarification forms are resolved, all data is "cleaned", the data transfer is sent to the sponsor as per the agreed specifications, and the data and the study files are completed and archived appropriately.
• Plan and arrange the trainings for new joiners and conduct refresher trainings for the Data Management team.
• Provide review and opinion in developing, revising, and maintaining core operating procedures, working instructions, and technological process improvements.

Candidate Profile
• Post-graduate in Life Sciences or Pharmacy or equivalent education.
• At least 2 years of relevant experience.; or equivalent combination of education, training and experience

Additional Information:
Experience: Min. 2 years
Location: Mumbai- Maharashtra
Education: M.Pharm, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Other
End Date: 26^th October, 2014