Senior Lead Clinical Data Manager (remote)

Your New Company! At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences. We are better together and together We Are Altasciences. About The Role The Senior Lead Data Manager is responsible for all data management activities from study start-up through database lock and archiving and independently supporting the needs of the clinical study and programs of studies. In addition, the Senior Data Manager has an active role in continuous improvement and acts as a leader in the department as demonstrated by successful mentoring and consistent study delivery over time. What You’ll Do Here

• Follow department and company standard operating procedures (SOPs), forms, templates and policies. Provide feedback and update these guidelines as needed.
• Act as the primary Data Management contact for the client and project team, proactively managing sponsor and interdepartmental expectations.
• Develop strong client relationships that are driven by consistent study delivery in terms of quality and timeliness.
• Develop, review, and maintain all study Data Management documentation.
• Coordinate with Database Developers to ensure effective database build and timely go-live to meet the needs of the project.
• Ensure the clinical database adheres to Clinical Data Acquisition Standards Harmonization guidelines allowing for optimal SDTM dataset programming. Suggest design for standard and non-standard data collection, identify any gaps in data collection, and challenge collection of unnecessary data.
• Define electronic case report form (eCRF) and edit check specifications to support data collection and analysis required per protocol.
• Take responsibility for and guide effective quality control (QC) review and user acceptance testing (UAT) of the clinical database prior to its release into production, including oversight of staff performing these tasks.
• Delegate and collaborate with Data Managers on data management cleaning activities including listing review, issuing and closing queries, and external vendor data reconciliation per protocol, department and client standards, and International Conference on Harmonisation (ICH)
• Good Clinical Practice (GCP) guidelines within the timelines expected by the client and project team.
• Ensure data are properly reviewed in accordance with the Data Management Plan (DMP) and department and sponsor guidelines and that cleaning is effective and timely.
• Track eCRFs to ensure appropriate updates and that all missing or discrepant data are queried appropriately. Monitor key study metrics and provide status reports to the sponsor and project team.
• Maintain the Data Management documentation for the trial master file (TMF) according to department and Project Management processes.
• Provide input on study timelines, identify risks, and communicate mitigation strategies to the Project Manager.
• Provide input into improving the efficiency of data management tasks.
• Lead and participate in intradepartmental or interdepartmental process and quality improvement initiatives.
• Oversee direct reports as assigned.
• Mentor and train other team members and/or develop training materials as needed.

What You’ll Need to Succeed

• Bachelor's Degree in programming, health-related sciences, or relevant field and 5-8 years of Data Management experience. Experience may be considered in lieu of education.
• Excellent verbal and written communication skills.
• Professional attitude and strong interpersonal skills.
• Ability to work well with a multi-disciplinary team of professionals.
• Client-focused approach to work.
• Flexible attitude with respect to work assignments and new learning.
• Ability to prioritize workload.
• Superior attention to detail.
• Understanding of clinical research and the relationship of Data Management in the clinical study process.
• Proven history of continuous improvement.
• Strong technical aptitude and ability to adapt to multiple data management platforms.
• Strong knowledge of electronic data capture (EDC) clinical data ma

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