Clinical Data Management
- Golden Opportunities
- 4 - 12 Years
- Chennai
- 4 years ago
- Email to a friend
- Report this job
Job Description
job_descriptionJob Role: Clinical Data Management
Location: Hyderabad
Candidate Qualification: Any Life Science Graduation
Candidate Specification: 4- 12 years in Clinical Data Management with mandatory Protocol review Experience.
Responsibilities :
Candidate Qualification: Any Life Science Graduation
Candidate Specification: 4- 12 years in Clinical Data Management with mandatory Protocol review Experience.
Responsibilities :
- Serves as primary operational contact for Study/Functional level.
- Exhibits strong project management and organizational skills to monitor study progress and manages Line management responsibilities of reporting CDMs.
- Effectively leads team of CDMs assigned to the protocol demonstrating strong interpersonal and people management skills
- Own proven team building skills and ability to foster partnerships across projects. Communicate effectively via oral and written communication skills to influence inform or guide others
- Exhibits strong knowledge in Oncology clinical trials and provide mentoring support to assist CDMs. Accountable for data management start up lock or database update activities. Oversee all studies assigned to reporting CDMs and suggest resolutions for the issues highlighted by CDMs independently
- Accountable to ensure that the issues noted during data management which impact the overall timelines are addressed informed to client and coordinate follow-up on the mitigation plans. Engage client to assist in the resolution of more complex issues
- Ensure that data management activities follow global and Program level standard requirements study timelines ICH-GCP guidelines Client SOPs and regulatory guidelines or regulations
- Work with other cross functional Team Leads for effective and timely resource allocations.
- As applicable and required attend study team meetings with CDM to provide oversight support during study start up meetings as needed. Provide leadership inputs as and when needed during regular meetings with internal and external stakeholders responsible for the assigned study
- Effectively uses available tools to gather information needed to manage study activities track study execution activities against the schedules defined and generate reports to review regular updates entire life cycle of the project
- Follow appropriate escalation pathway to inform internal as well as external stakeholders of problems and potential solutions
- Process studies if required
- Accountable for completion of all database lock activities of the reporting CDMs to the standards expected
- Attend all applicable study lock meetings for any assistance to CDM
- Undrstands the importance of data quality and uses this to drive all data management review to lock related activities daily basis
- Contributes to the establishment and/or development of best practices and ensures best practices are shared to key stakeholders to support consistency within a program
- Ensure CDMs deliver study activities/timelines to client within the set timelines and per quality expectations for the process
Employement Category:
Employement Type: Full timeIndustry: PharmaceuticalFunctional Area: PharmaceuticalRole Category: Data ManagementRole/Responsibilies: Clinical Data ManagementContact Details:
Company: Golden OpportunitiesLocation(s): Chennai+ View Contact
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