Sr. Director, Data Management

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.

These customers have new therapeutic ideas, but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.

Summary:

The Senior Director Data Management (EMEA & NA), (SrDDM) leads and oversees operational activities of the Allucent Data Management (DM) department to one or more global regions.

The SrDDM has (global) people management responsibilities and controls and monitors Data Management activities, providing leadership and expertise in relevant technical areas and cross-functional initiatives, including the development of departmental processes, tools and training of staff. 

The SrDDM is a member of the Data Management staff.

Key Responsibilities:

Clinical Data Management

• Contribute to the identification, development and implementation of the business strategy for the Data Management department
• Contribute to development of annual revenues, sales, profit and operational targets for the Data Management department
• Evaluate and contribute to the development of the Data Management department strategy and tactics planning
• Develop, agree and approve operating procedures / business processes
• Manage direct reporting staff and oversee and manage (global) teams
• Review and verify the needs of the department for tools, processes, resourcing, and personnel and take action upon these needs
• Review and verify the availability of required capable resources for the area and take action upon these needs
• Verify the availability of required capable resources for the area
• Collaborate and ensure open communication with other functional groups and departments
• Report to the leaderships team
• Work closely with the (Executive) (Senior) Directors and Vice President, Global Head of Data Management, Project Directors and functional heads of other departments so that global consistency, focus and development are achieved across the company
• Oversee contractual and financial aspects of projects, utilization rate and profitability
• Verify activities meet and integrate with organizational requirements for quality management, health and safety, legal stipulations, environmental policies and general duty of care

• Ensure consistency and standardization of data management to complete project deliverables on schedule and according to quality standards and requirements of the study
• Recognize and solve potential problems and evaluate effectiveness
• Oversee Sponsor relationships
• Assist in audits and regulatory inspections
• Review and approve key DM documents and deliverables (if applicable)
• Serve as project advisor to project teams regarding operational aspects of a project
• Plan and report resources required including management of tasks, timelines, risk and quality
• Recognize potential problems across projects, propose and develop short-term and long-term solution and improvement strategies and evaluate effectiveness
• Apply expertise to identify gaps and proposes solutions to improve efficiency of data management tasks to improve overall quality of data management deliverables.
• Collaborate with other Allucent departments and teams to ensure overall success of project.
• Serve as project advisor/consultant to cross-functional project teams regarding technical and operational aspects of project
• Apply expertise to identify gaps and proposes solutions to improve efficiency of data management tasks to improve overall quality of data management deliverables.

Management & Learning Development

• Actively manage and mentor Data Management staff in general skills, project management skills, internal company processes and for project-specific tasks
• Conduct performance evaluation, perform performance reviews and support team member personal development plans
• Proactive