Data Manager – SDTM

March 31, 2022 (Early Applications will be given preference)

Dhaka, Bangladesh

We are looking for an experienced data manager with SDTM experience, who can lead a team of data curators and provide oversight, quality control and feedback. The incumbent should be able to leverage their proficiency SDTM expertise and lead data activities of his/her team on multiple studies. A strong sense of responsibility, accountability, proactiveness and good communication skills is a must for this position. Please DO NOT APPLY if you do not possess such skills.

We are looking for a dynamic individual capable of consistently delivering & exceeding expectations in the following:

• Bachelor’s degree preferred, In lieu of Bachelor’s degree, equivalent related education and experience.

• 3+ years of experience as a Data Manager and 2+ years managing projects.
• SDTM programming experience is desired but not mandatory.
• Experience working in the clinical research industry within a CRO/Pharma.
• Experience working in a matrix-structured environment is preferred.
• Experience collaborating with a study team.

• Management & Coordination of Data Management Activities.
• Training, Monitoring & Mentoring.
• SDTM Mapping Activities.

• Acts as Functional Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups.
• Coordinate the work of the assigned Data Management/Data Operations team.
• Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations.
• Prepare, track, and implement operational plans such as Project Plan, Data Management Plan, Quality & Oversight Plan to ensure proper Data Management set-up, conduct and closure activities.
• SDTM Mapping and QC experience including developing SDTM mapping specs and datasets and e-submission requirements (annotated CRF, Define, sdrg).
• Applying CDISC know-how and proficiency in SDTM and ADaM, to create and validate datasets/analysis files, tables, listings, and figures (TLFs).
• Provides project specific training to internal and external audiences as required.
• Responsible for management of assigned projects / programs, including changes in scope and participation in internal project review meetings.
• Monitors and communicates project progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management.
• Plan, manages and requests resources for assigned projects.
• Develop and maintain project plans, specifications, and documentation in line with SOP requirements.
• Maintains documentation on an ongoing basis and ensures that all TMF (Trial Master File) filing is complete and up to date.
• Plans for and creates necessary documentation to support internal and external audits; participates in such audits.
• Participates in, and presents at internal, Sponsor, third-party, and investigator meetings.
• Train and mentor data management staff.
• Prepares input for and participates in proposal bid defense meetings.
• Maintains proficiency in Data Management systems and processes through regular training.

• Excellent communication skills (verbal, written and interpersonal).
• Data Management experience and experience working on a clinical trial is preferred, but not mandatory.
• Exposure to any one (or more) of the data processing tools/languages such as – R, SAS, Python, MS Access, is an added advantage.
• Ability to work well within multi-disciplinary teams and has proven abilities to coordinate and drive projects in a matrix organization and handling multiple priorities/projects.
• Working knowledge on US healthcare data is desired.
• The ability to deal effectively with sponsors and internal customers at all levels.
• Share technical knowledge and solutions to problems with other members.
• Ability to relate with a diverse group of people.
• Strong aptitude to learn new technologies.

• Competitive salary and long-term benefits with excellent career opportunity in a focused & stable organization.
• Most importantly, a friendly work environment with opportunity to learn from a number of highly skilled mentors.

If you believe you are the right candidate, then send your CV to career@relisource.com with the exact subject line “DM_31082021” by March 31, 2022.

IMPORTANT: Resume attached without above subject line will not be processed. Your CV must include your photograph.