Senior Data Management Specialist
4 weeks ago
We are seeking an experienced Senior Data Management Specialist to join our team at Tech Observer.
About the RoleThis is a challenging and rewarding opportunity for a skilled data management professional to lead and manage data-related activities for assigned projects from start to finish. The successful candidate will be responsible for creating and executing project work plans, ensuring quality and compliance with regulatory requirements, and providing timely updates to stakeholders.
Key Responsibilities:- Create and execute project work plans, revising as necessary to meet changing needs and requirements.
- Oversee data management activities for assigned projects, including study start-up, conduct, and close-out, within agreed timelines, quality, and cost.
- Ensure quality and compliance with protocol, SOPs, ICH-GCP, and applicable regulatory requirements.
- Prepare, review, and approve project-specific essential documents, plans, deliverables, etc.
- Establish and update the data management trial master file (DMTMF) on a regular basis.
- Perform manual reviews of data listings, quality control checks/reviews, SAE reconciliations as needed.
- Provide periodic progress/status reports/updates to function heads, internal and external stakeholders.
- 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.
- Support external audits, certification audits, and regulatory inspections from DM in consultation with HOD.
- Conduct training for project teams and/or DM teams as needed.
- Manage and assign resources and responsibilities for assigned projects.
- Communicate project expectations/requirements/scope adequately to project teams 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 actions.
- Cultivate, mentor, motivate, and supervise project team members and contractors to achieve their assigned work.
The estimated salary for this role is $120,000 - $180,000 per annum, depending on experience. In addition to a competitive salary, we offer a range of benefits, including health insurance, retirement plan, and paid time off.
What We OfferAt Tech Observer, we value diversity, equity, and inclusion. We strive to create a workplace that is welcoming and inclusive for all employees. If you are passionate about data management and looking for a challenging opportunity to grow your career, please apply today.
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