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- Attract, develop, and retain top talent; provide direction, real time situational mentoring, career development guidance. Actively work to promote team building and positive culture within the department.
- May act as designee of the Senior Director where appropriate
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Director, Clinical Data Management - Mississauga, Canada - AstraZeneca
Description
Director Clinical Data Management
Hybrid work (3days from the office, 2 days from home)
The role holder will be responsible for developing the Clinical Data Management (CDM) strategy for either the therapeutic area/indication and/or strategic roles at DM organisation level. Will be responsible for CDM quality, management of external partners, internal training, and delivering against metrics for the CDM Function. Will be a member of the Data Management Leadership Team and is expected to provide CDM expertise to influence decision making with the relevant partnering teams , Biometric Data Leadership Team, TA aligned Biometrics team, Regulatory, Patient safety and other functional colleagues. May be responsible for managing a team of Clinical Data Management specialists in one or more countries, that are assigned to clinical drug/non-drug projects. Will drive a culture of delivering to established milestones with the highest degree of customer satisfaction, emphasizing communication and transparency of operations.
Typical Accountabilities
Establish asset level strategies to ensure consistency, efficiency, and excellence in the application of CDM standards, implementing advanced predictive data monitoring practices and knowledge sharing within a TA.
o Capacity Management and Alignment for DM: Ensure appropriate resources are available (internal and/or external) and assigned appropriately to meet demand of CDM function
o Manage relationships with internal and external partners to ensure the CDM strategy is appropriate in the wider context , TA Directors, Training and Risk Management, Quality Management, Statistics and Programming, Study Management Teams, Digital Health, external vendors.
Education, Qualifications, Skills and Experience
Essential:
• University or college degree in the life sciences or related subject, pharmacy, nursing or equivalent relevant degree. Advanced degree is a plus but not mandatory.
• Significant experience in a pharmaceutical, biotech, CRO or Regulatory Agency
• Strong leadership capabilities including ability to drive strong following in reporting lines, and people management skills
• Ability to work independently, under pressure meeting tight deadlines, demonstrating high level of initiative and flexibility.
• Excellent organizational and analytical skills
• Strong technical and problem-solving skills with experience on computer systems for Data Management.
• Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP) and relevant regulatory requirements
• Experience with Clinical Trial Operations and a clear understanding of clinical data from internal as well as external sources
• Demonstrated experience to manage complex projects and cross-functional teams including delivering to project and portfolio metrics
• Demonstrated strong communication, interpersonal and negotiating skills in relating to colleagues and associates internal/external to the organization and leveraging of those competencies to ensure continuous progress
• Strong track record of building successful relations with supervisors, peers, direct reports, suppliers, customers, partners and stakeholders is essential
• Strong strategic experience and business analytics ability to distil research needs and define business, technical, and operational requirements.
Desirable:
• Certified Clinical Data Manager (CCDM) via the Society of Clinical Data Management
• Expert reputation within the business and industry
• Extensive knowledge of the latest technical and regulatory expectations
Date Posted
22-May-2024Closing Date
04-Jun-2024
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