Job Description
Brief Responsibilities
* Primary point of contact (POC) for internal and external stakeholders for DM related activities for assigned projects/ studies.
* Creates and executes project work plans and revises as appropriate to meet changing needs and requirements.
* 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 with 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.
* Coach, mentor, motivate and supervise project team members and contractors, and influence them to take positive action and accountability for their assigned work.
* Other responsibilities as delegated by the reporting manager/ HOD or senior management.