Job Title : Sr. Clinical Data Coordinator
Job Description :
- The Sr. Clinical Data Coordinator provides comprehensive data management expertise to Data Management.
- The position also requires to provide efficient, quality data management products that meet customer needs. Provide leadership either in the role of the Data Operations Coordinator (DOC), or in a leadership role in a specific Department task.
- Serve as Data Operations Coordinator (DOC) for one or two global studies with fewer than 10 operations staff (excludes DE), or serve in a leadership role to a specific DM Task. (See Responsibilities Document for role description)
- Manage delivery of projects through full data management study life-cycle (with minimal guidance)
- Manage project timelines (with guidance from DTL or Manager)
- Management of quality (with guidance from DTL or Manager)
- Determining resource needs (with guidance from DTL or Manager)
- Identify Out of Scope Work
- Serve as back-up for Data Operations Coordinator or Data Team Lead (with guidance)
- Perform comprehensive data management tasks including data review, writing and resolving data clarifications
- Perform database designer activities for technologies not requiring extensive programming
- Perform comprehensive quality control procedures
- Independently bring project solutions to the CDM team.
- Solves issues through using the global issue escalation/communication plan.
- Consult with Standards Group for process issues; communicate ideas for process improvement
- Assist in developing and implementing new technology.
- Understand and comply with core operating procedures and working instructions.
- Perform other duties as directed by the Data Operations Coordinator, Group Manager.
- Meet objectives as assigned.
- Develop and maintain good communications and working relationships with CDM team.
- Interact with CDM team members to negotiate timelines and responsibilities.
Educational Qualifications : A Bachelors/ Masters degree (preferably in Health Sciences, Science or Clinical) or Other relevant degree
Experience : Minimum 1-2 years of relevant work experience (clinical trials experience in function similar to DM) and a total work experience of at least 4 years.
Required Skill Set :
- A background in Medical Terminology, Pharmacology, Anatomy, and Physiology required for many tasks.
- A thorough understanding of clinical drug development process.
- The position expects excellent organizational, communication, and data management skills.
- The incumbent must be detail oriented.
- Position requires long periods of keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time.
- Understanding of data management process from study start-up through to database lock
- Knowledge of operating procedures and work instructions and the ability to apply them in practice.
- Understand basic financial management concepts.
- Able to present information effectively to individuals and small groups.
- Able to prepare written communications using correct spelling, grammar and punctuation
- Able to make independent decisions within scope of authority and considers the impact of decisions on other groups/people.
- Basic understanding of Drug Development Process and its relevance to Data Management
- Able to motivate and lead teams to reach defined objectives.
- Effective team management skills including conflict resolution, delegation, and change management.
- Excellent interpersonal skills are required.
- Comprehensive understanding of database technologies.
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