Require Senior Clinical Data Manager in i3 global

At i3 Global, We believe in science for the sake of people—in the end, it’s about better patient care.
Because we are a service organization through and through, we’ll build a relationship to suit your specialized needs. Tell us what you need and where in the world you want us to be, and we will deliver.
We insist that our science be rigorous and our business approach straightforward. Similarly, our habit of maintaining strictly audited quality in all that we do is, to us, another manifestation of integrity.

Post: Senior Clinical Data Manager

Job Description:
Assumes overall responsibility for the successful execution of the data management projects assigned to them. Lead DM with minimal supervision for several midsize to complex projects/partnerships.
Writes, updates/reviews and approves all required trial data management documentation, documents and presents CRF completion guidelines at investigator meetings.
Performs any data management activities related to projects, as needed.
Provides leadership and may supervise/train Data Management staff assigned to work on their projects, including Clinical Data Coordinators and other Data Mangers, supports training of project staff.
Monitors the progress of all data management activities for the project to ensure that project timelines are met. Directs activities associated with data integration and data.
Monitors the quality and coordinates all data management QC activities for the project.
Establishes and coordinates the timely completion of the database lock procedures.
Understands and follows the process if the database needs to be unlocked
Monitors the data management process for the project to ensure that work is proceeding in an efficient manner.
Establishes timelines to perform an audit and oversees activities of audit team. Ensures adequate preparation for internal and external database and data management audits, can respond knowledgeably and confidently to issues or questions that arise during audits
Serves as Data Management contact with sponsor managing their expectations, noting and responding to out-of-scope work. Liaise with clients on limited basis and produce trial progress reports
Some business development work may be required, such as input to proposals and client presentations.
Remain informed of new developments in data management that are relevant to the industry.
Participate in the development of Standard Operating Procedures (SOPs) and guidelines
Provide feedback to team members and supervisors (if applicable) on individual performance and contributions to the overall team effort in a constructive manner

Some line management activities may be required with the ability to guide and counsel direct reports/mentees on their career development.
Work effectively with international peers and sponsors, as needed.
Assist in directing global data management projects to ensure the seamless provision of services.
Have thorough understanding of data management budgets and can communicate out of scope requests to the project manager.

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Candidate Profile:
Relevant experience working on Oracle Clinical (OC) in study based activities within a CRO/Pharmaceutical industry.
Extensive experience in leading data management activities for multiple mid size to large/complex studies.
Thorough knowledge of applicable regulatory rules and guidelines; e.g. ICH, GCP.
Demonstrated proficiency in the data management process.
Possesses a positive attitude and works well within onsite teams and off site teams
Basic Programming Knowledge.
Previous team leadership experience or strong leadership skills.

Additional Information:
Experience: 1-3 years
Location: Hyderabad
Education: B.Pharm, M.Pharm, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR, data management
End Date: 15^th Feb, 2012