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Job ID : 182442BR
Position Title : Lead Clinical Data Manager
Division : PHARMA
Business Unit : Global Develop NPH
Work Location : Hyderabad
Functional Area : Research & Development
Therapeutic/Disease Area : Immunology & Dermatology
Job Type : Full Time
Employment : Type Regular
Job Description : Ensure quality and timely clinical data delivery for multiple CPO local studies and projects outsourced to international Contract Research Organizations (CROs) and establish appropriate application of data standards, monitor CRO progress, and perform quality assurance review of key clinical data management (CDM) deliverables.
Major Accountabilities :
- Serve as Project Data Manager for multiple projects/trials from 1-2 business units (BUs) and providing professional Data Management input to Clinical Trial Teams (CTTs) and CPOs as needed.
- Responsible for ensuring consistency of protocols, project CRFs, clinical databases for all trials within assigned projects and provide technical feedback to CROs as needed.
- Provide CDM input to study protocols and Study Specification Worksheets (SSW) for CRO proposal requests; provide input on CRO selection.
- Develop CDM presentations for Investigator Meetings, CRA workshops, and Project Kick-off meetings, and Validation and Analysis Plans (VAPs) as appropriate.
- Ensure complete and consistent medical term coding using appropriate standard dictionaries; ensure consistency of serious adverse event data across clinical and drug safety databases.
- Monitor clinical data quality and progress of trials outsourced to international CROs; drive corrective actions as needed; ensure proper integration of third-party/non-CRF data as applicable.
- Proactively identify project threats and resolve issues with clinical trial teams; escalate to CDS management if necessary and appropriate.
- Ensure up-to-date and accurate tracking of report status and progress of data management for allocated trials and be proactive to ensure smooth and successful timely locking of databases.
- Ensure timely completion of data management archiving; as necessary; respond to Health Authority/FDA/audit requests pertaining to project-specific data management issues.
- Provide input, review, and maintenance of local working practices and standards.
- Participate in the development of a Data Management organization through his/her leadership role within the DM Group for CDS.
- Participate in clinical & non-clinical special projects. May assist in hiring, coaching, training, and mentoring of other Data Management staff.
Minimum requirements :
University or college degree in life science, pharmacy, nursing statistics, biostatistics or equivalent relevant degree. Fluent English (oral and written).
- Ideally 4 or more years experience in drug development, with at least 3 years in Data Management activities.
- Experience in managing outsourced studies or working for a CRO.
- Understanding SAS output and introductory level skills with SAS.
- Thorough understanding of physiology, drug development process, clinical trial methodology, GCP, medical terminology, and coding.
- Project team leadership experience; good organizational and project management skills.
- Good technical and problem solving skills.
- Ability to work independently, under pressure, demonstrating initiative and flexibility.
- Attention to detail and quality focused.
- Good interpersonal and communication skills and ability to operate effectively in an international environment.
- Good negotiation skills.
- Ability to mentor, coach within Data Management and cross functionally, and train internal and external partners.
