Manager - Clinical Data Management (CDM) home or office based in Portugal

PURPOSE

The purpose of this Manager – Clinical Data Management job is to manage and support a team of Data Management professionals to efficiently produce databases that meet customer requirements. Can act as the client's primary point of contact for data-related activities and processing, tracking, and managing clinical data and documentation. Additionally, ensure that data is processed and tracked in alignment with regulatory and quality standards.

You must apply in English to be considered.

Responsibilities – Manager – Clinical Data Management:-

Project Management:

• Project manages all data deliverables; liaising with project stakeholders such as project and data operations teams; and administering clinical documentation.
• Provide expert review and guidance for production of Data Management deliverables including CRF/e-CRF, database design and set-up, validation definition and programming, Data Management Plan and database deliverables to internal and external customers.
• Provide technical advice and solutions with internal and external customers to solve problems and improve efficiency. Participate in the development and implementation of new processes and technology.
• Ensure that staff is trained and compliant with current operating procedures and work instructions and project scope of work.
• Mentor staff members to develop Data Management process, system, and drug development expertise.
• Perform data management activities as required.
• Provide operational input into proposals and scope of work.
• Participate in proposal defenses.
• Attend customer meetings and lead discussions of project requirements and strategic planning.
• Understand scope of work, budget, and scope assumptions.
• Identify out-of-scope work and provide revised costs with supporting documentation.
• Ensure project milestones are met according to agreed timelines.
• Actively manage quality throughout project.
• May be Project Manager/Project Lead for a major study or a series/group of studies. Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work

Team Management:

• Manage a team of professional Data Management staff to efficiently produce databases that meet customer requirements. Size of team could vary from 5+ upwards -15, depending on the Data Management Function.

• Define and prioritize resource requirements and manage resource assignments across projects. Directly responsible for utilization of staff.
• Assess and document competency of staff to satisfy position responsibilities.
• Identify and address professional development/training needs of staff.
• Regularly set goals. Appraise, manage and document performance.
• Propose salaries, promotion and termination actions.
• Actively contribute to recruitment of new staff.
• Implementation of department/office objectives.
• Address employee relations issues and resolve problems.
• Approve actions on human resources matters.
  

Minimum Skills & Experience:-

• Advanced knowledge of Data Management processes and systems gained from a minimum of 5 years hands on experience as a clinical Data Team Lead (DTL)
• Understands basic management approaches such as work scheduling, prioritizing, coaching and process execution.
• Proven leadership skills.
• Solid understanding of clinical drug development process.
• Excellent written and oral communication skills in English.
• Excellent organizational skills and demonstrated ability to manage projects.
• Effective problem-solving skills.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Right to live and work in the recruiting country

Desirable Skills, Experience & Knowledge:-

• Excellent experience of using standard Clinical Data Management platforms (IBM-CD experience a plus)
• Experience of implementing and utilising KPI’s an advantage
• Experience of setting budgets an advantage

Required Education:-

Bachelor's Degree Clinical, biological or mathematical sciences or related field, or nursing qualification

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