Senior Data Manager
New Haven , CT 06501
Posted 2 weeks ago
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With limited support from reporting manager, lead and provide oversight of the delivery of Cogstate data management services to companies conducting clinical trials.
- Independently execute and oversee data management processes for new clinical trials during start-up phase and manage the data during study conduct through close-out phase in line with Company SOPs and best practices, reporting and escalating to management staff as appropriate.
- Identify and/or leading process improvement initiatives, such as evaluating new systems and services while thoroughly understanding internal processes and customer needs. Update SOPs/WIDs/guidelines/templates as necessary.
- May also include acting as a Subject Matter Expert (SME) representing Data Management department on internal or external initiatives.
- May also include acting as Data Management Team Lead with direct supervision of Data Management staff.
- Provide oversight of data management activities for more complex studies, or a portfolio of studies
- Create study-specific data management plans for clinical trials
- Thorough understanding and review of clinical trial protocols
- Hold DM-specific kick-off meetings with sponsors/CROs
- Create study-specific database build specifications
- Create data transfer specifications
- Perform UAT/test of new study databases
- Set up data management tracking tools
- Manage custom software build and database set-up processes, as needed
- Write and review supporting documentation for data management including Data Quality Monitoring Plans and Data Management Plans
- Review and understand sponsor custom file format specifications and liaise with programmers as needed to determine feasibility and timelines
- Thorough understanding of project scope of services related to data deliverables
- Complete data management services of a portfolio of studies, executing against project plans and scope of services
- Monitor study data in Cogstates data management system for quality and resolution of data discrepancies
- Manage quality control and delivery of data transfers to customers
- Liaise with Cogstate Scientific and Statistical Analysis team as needed to coordinate custom programming of data extracts and communication with sponsors regarding statistical analyses
- Regular review of study timelines and data deliverables
- Rigorously file all study documents and e-mail correspondence
- Support client information and data reporting needs: timely communication and regular external and internal reporting on project progress, address and resolve all issues, anticipate issues, work internally to develop resolutions that provide client satisfaction and meet Cogstates business interests
- Manage site communications relating to data monitoring and data-related support issues
- Manage external and internal communications about data management timelines
- Prepare for client audits: ensure all study data-related information and filing is up to date and review all key study information in preparation for interactions with auditors
- Regular reviews of study timelines, tracking of all internal work and re-work, and coordination with project managers to ensure all data management activities are adequately supported financially by study budgets
- Identify and lead one or more of Cogstates continuous process improvement initiatives by seeking to understand client needs and engaging Cogstate staff across the company
- Train and mentor new members of staff, including planning and execution of full induction schedule, and delegation and supervision of tasks
- If acting as SME, serve as the main point of contact for issues related to the area of expertise including but not limited to managing all associated materials, training, and process improvements and liaising with other departments as necessary
- Supervise and develop reporting Data Coordinators, Associate Data Managers and Data Managers. Appropriately challenge, guide and provide growth opportunities
- Work with direct reports to establish quarterly goals and perform performance reviews
- For junior staff, delegate tasks and bundles of tasks while retaining control over the quality of the work and the identification and resolution of issues
- Provide guidance for Cogstates process improvement initiatives directly related to data management services and/or deliverables
- Ensure overall compliance and adherence to Cogstate internal procedures and study specific scope of services for studies managed by reporting staff
- Oversee the teams portfolio of studies and regularly report status updates and escalate issues to Data Management Director
- Work with Data Management Director and Associate Directors on resource planning and hiring of new staff
- Provide back-up support for department manager as appropriate
- Bachelor's degree in a business, scientific or a technical discipline (psychology, nursing, biology, sociology, computer science or engineering) or demonstrated professional experience, preferably with data, software or other technical discipline
- Minimum 5 years related work experience with a minimum of 3 years clinical trial experience
- Prior supervisory experience desired
- People skills: within the team, and with customers and third-party providers, strong desire to learn, to seek feedback on performance and to learn quickly
- Communication skills: both written and oral, providing operational support
- Work skills: eye for detail, methodical, problem solving, comfortable working in a fast-paced environment, high level of computer literacy (Excel/Office/PowerPoint savvy)
- Good organizational skills: handling multiple tasks, establishing and managing competing priorities, ability to work independently and to be proactive
- Aptitude for understanding and leading ones work from Industry, Regulatory and Quality, Commercial and Financial concept
A Cognitive Science Company on a Mission
Our mission at Cogstate is to optimize the measurement of brain health to advance the development of new medicines and to enable earlier clinical insights in healthcare. We are driven by the notion that through our work we impact the health of communities by delivering solutions that combine breakthrough science with advanced technologies. We are inspired by the dedication of researchers and the resilience of patients, and we are strengthened by our 20-year heritage supporting them. We are always working to simplify the complex with solutions that offer insights and hope for the future of healthcare, particularly dementia-related diseases and rare and pediatric disorders
Cogstate Core Values
Do the Right thing
- We are honest and dependable. We keep our promises, act with integrity and foster trust through fairness, transparency, and open communication
Think like a customer
- We see our customers challenges as our own and strive to help them succeed. We listen, learn what makes them tick and adapt to creatively meet their needs.
Take care of each other
- We work together to tackle big challenges that can only be achieved through the collective and caring efforts of diverse individuals. We show appreciation, value differences, and celebrate wins.
Lead with science
- We are determined, curious thinkers who use knowledge and data to challenge the status quo and redefine what is possible. We are experts in our fields who are trusted by our customers.
- We are accountable to excellence and hold ourselves to high standards. We are problem solvers at heart and quick to both identify obstacles and bring solutions
- We show resilience in the face of hardship to do the messy work of innovating. We stick to difficult tasks with grit and determination. We iterate, experiment, and embrace failing forward.
See the big picture
- We are driven by an understanding that the work we do matters. Our personal connections to the mission may be different, but we know our why and it motivates us to do our best work.
Cogstate is committed to building and maintaining a fair, diverse and inclusive workplace where the personal worth of each employee is recognized, and all are respected and valued for their differences. We believe that having a team of individuals with different backgrounds, skills, experiences, and attributes makes us a stronger organization, including those differences gained on account of gender, gender identity, age, disability, ethnicity, marital or family status, religious beliefs, cultural or socio-economic background or sexual orientation. To learn more, please read our diversity policy here.