Description:

　　POSITION SUMMARY:

　　The Senior Manager, Clinical Data Management is responsible for overseeing clinical data management and safety strategy and activities for the clinical trial portfolio. This role will oversee staff performance, clinical systems, procedural creation and updates, workflow, metrics, and goals.

　　ACCOUNTABILITIES:

　　• Subject matter expert for data management activities and data structure standards

　　• Oversees systems, extract, and processes for clinical trial data management activities, including oversight of Electronic Data Capture system and alignment with other data sources

　　• Manages and standardizes safety event reporting against regulatory requirements and best practices

　　• Assesses and manages applicable data vendor partnerships to maximize effectiveness

　　• Collaborates within company for data governance and accessibility related to CRO clinical trials

　　• Collaborates closely with project management and operational teams to ensure data management activities align with specific study requirements

　　• Fosters partnerships with Clinical Information Technology and Biostatistics to ensure data synergies and standardization across trials

　　• Advises on resource planning/allocation based on forecasted clinical activities and actual study/project metrics

　　• Oversees processes for data cleaning/review/reconciliation activities and utilizes metrics and patient trackers to monitor data

　　• Prepares, tracks, and implements standard plans to ensure proper governance of data management study set-up, conduct and closure activities

　　• Assess current state of technology and proactively plan for implementation of new database modules or requirements ahead of needed dates

　　• Ensure complete, accurate and timely documentation for all projects/studies according to established SOPs

　　• Assesses risks, anticipates potential problems, and creates contingency plans to mitigate.

　　• Mentors staff to develop new capabilities and nurtures an environment of creativity

　　• Drives staff efficiency, productivity, and engagement by understanding strengths, weakness, and drivers.

　　Additional Skills & Qualifications:

　　REQUIRED QUALIFICATIONS:

　　Knowledge of:

　　• Strong project management skills

　　• Strong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials

　　• Knowledge of CRF design, clinical study reporting requirements, including SAS programming

　　• Experience with risk assessment and mitigation

　　• Strong critical thinking and problem-solving skills

　　• Ability to manage and tailor stakeholder communication

　　• Knowledge of the clinical study development and execution pathway.

　　• Clinical operations and efficiencies.

　　Ability to:

　　• Meet key deadlines and manage multiple projects and tasks simultaneously.

　　• Lead a team

　　• Write and communicate articulately and concisely.

　　• Work proactively, take initiative, and assess risk.

　　• Provide strong teaching and mentoring skills.

　　• Must exemplify our Standards.

　　Education and/or Experience:

　　• Bachelor’s degree in scientific or health related field. MBA or MPH preferred.

　　• Minimum 7 years of clinical trials experience with at least 3 with oversight of data management activities

　　• Minimum 3 years people management experience

　　Diversity, Equity & Inclusion

　　At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

　　Hiring diverse talent

　　Maintaining an inclusive environment through persistent self-reflection

　　Building a culture of care, engagement, and recognition with clear outcomes

　　Ensuring growth opportunities for our people

　　Actalent is an equal opportunity employer.

　　About Actalent

　　Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.