Within this position, your duties will include:
- Engage client data management during start up.
- Create protocol folder(s) for study documentation.
- Add entries into individual protocol spreadsheet.
- Review Statement of Work (SOW) for study scope.
- Ensure start-up packet delivery to clients.
- Contact clients for initial study discussion and determine authors of Data Transfer Specifications (DTS).
- Provide recommendations and alternatives to optimize data quality.
- Collaborate with clients to finalize Data Transfer Specifications (DTS).
- Obtain final client approval on Data Transfer Specifications (DTS).
- Act as a data liaison between Clinical Data Management and all other Lapcorp departments and business units.
- Consult with Medical Affairs via a Med/Tech Affairs Request Form
- Collaborate with Project Management proactively and reactively regarding study questions.
- Manage and resolve issues with Specimen Management.
- Initiate data changes with the appropriate department and revise all non-compliant requests.
- Partner with other Lapcorp departments and business units, and provide integrated support and process improvements as needed.
- Create standard data transfer format(s) in compliance with client requests while adhering to both internal processes and regulatory standards.
- Build and modify Data Transfer formats as needed.
- Create test data if needed.
- Quality Check (QC) test files.
- Deliver test files to clients and log into the metrics tool.
- Obtain client approval and store auditable documentation.
- Provide ongoing client support (study maintenance).
- Create global transmission instructions.
- Schedule appropriate frequency of data transfers.
- Address errors and client issues including queries.
- Participate in study-related meetings.
- Collaborate with clients regarding study modifications.
- Confirm changes and send files as needed.
- Maintain auditable documents.
- Facilitate Data Management functions of end-to-end data lock processes.
- Represent Clinical Data Management in client visits, audits, inspections and bid defenses as needed.
- Collaborate with clients regarding new service requests.
- Support billing of services as needed.
- Attend training to increase Data Manager’s capabilities (including corporate, departmental and sponsor-related training).
- Minimum Bachelors Degree in Life science/Pharma/Technology/Computer application with technical and programming background within healthcare or clinical research domain.
- Customer Service experience.
- Data Management and/or Clinical Trials experience.
- Pharma and/or health industry experience preferred
- Ability to use standard Microsoft suite of software products.
- Conversant with databases and database terminology.
- Strong technical aptitude.
- Strong organizational, planning and critical-thinking skills.
- Well-polished, inclusive, and engaging communication skills (written and verbal).
- Strong negotiation skills to facilitate, guide, influence, and produce a unified approach within a global, cross-functional environment.
- Ability to handle multiple tasks in a timely and professional manner under demanding conditions.
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