We are looking for a seasoned Project Delivery Leader to join our team.
The ideal candidate will have a strong background in project management, people management, and problem-solving.
Key Responsibilities:
* Provide leadership, mentorship, and line management to a team of professionals.
* Manage day-to-day resourcing activities, including workload balancing, task delegation, and resource allocation.
* Oversee performance management processes, including goal setting, regular feedback, career development planning, and conducting annual performance reviews.
* Establish, monitor, and report on corporate and role-based Key Performance Indicators (KPIs).
Oversight of KPIs:
* Utilize KPI data to identify trends, drive process improvements, and ensure functional teams are meeting performance targets and quality standards.
TMF Strategy & Budgeting:
* Hold responsibility for supporting TMF-related activities during the pre-award budget planning phase.
* Contribute to the operational strategy for TMF management, ensuring inspection readiness, data integrity, and compliance with all applicable regulations.
* Drive the implementation and adoption of TMF systems and best practices within the organization.
Operational Excellence & Compliance:
* Ensure all clinical operations activities, particularly those related to the TMF and site monitoring, adhere strictly to Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements.
* Act as a subject matter expert during internal/external audits and regulatory inspections pertaining to TMF documentation.
Qualifications:
* A Bachelor of Science (BSc) or master's degree in life science.
* Minimum 9 years relevant experience in pharmaceutical or CRO industry with increasing levels of responsibility.
* Strong knowledge of regulations, standards, and guidelines such as ICH E6, 21 CFR Part 11.
* Strong leadership skills.
* Relevant therapeutic area experience.
* Experience in project management, people management, problem-solving, and team leadership.
* Ability to deal effectively with sponsors and internal customers at all levels.
What We Offer:
* A competitive compensation package.
* Comprehensive benefits.
* The opportunity for personal and professional growth in a rewarding environment.