Key Responsibilities
Primary point of contact (POC) for internal and external stakeholders for DM related activities for assigned projects/ studies.
Overall responsible for DM activities for assigned projects from beginning to end including study start-up, study conduct and study close-out activities within agreed timeline, quality and cost.
Ensure quality and compliance with protocol, standard operating procedures (SOPs), ICH - GCP and applicable regulatory requirements for assigned projects.
Prepare/ revise, review and/ or approve project specific essential documents, plans, deliverables, etc.
Ensure data management trial master file (DMTMF) is established and updated on regular basis for assigned projects.
Perform manual review of data listings, quality control (QC) checks/ reviews, SAE reconciliations on need basis.
Provide periodic progress/ status reports/ updates to function head – CDM/ head of department (HOD), internal and external stakeholders for assigned projects.
Lead and participate in project specific meetings and teleconferences.
Develop new or revise existing DM SOPs.
Provide feedback for continuous improvement of SOPs from DM and other cross functional SOPs.
Provide support for external audits, certification audits and regulatory inspections from DM in consultation HOD.
Conduct training for project team and/ or DM team, on need basis.
Manage and assign resources and responsibilities for assigned projects.
Communicate project expectations/ requirements/ scope including any updates adequately to project team in a timely manner.
Assist HOD in interview and selection of new employees in the department/ function, if required.
Proactively identify and communicate potential risks/ challenges/ issues to relevant stakeholders and take timely necessary actions.
Proactively communicate any significant change in the project scope to business development team, in consultation with the HOD.
Other responsibilities as delegated by the reporting manager/ HOD or senior management.
