Director Clinical Operations, Head of CTS

 

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Director Clinical Operations, Head of CTS 

The Director, Head Specialist Clinical Trials Group Leader is responsible for providing leadership and overall strategic management of the Specialist Clinical Trials (SCT) group to ensure standardization of the various administrative tasks in support of the Clinical Trial Managers within Clinical Operations, including developing working practices and standards to ensure consistent, high-quality execution across studies and platforms. The role is a part of the Operations Extended Leadership Team led by the VP of Operations. This role interacts with and influences all levels within Clinical Operations and other clinical study personnel for clinical trials across portfolios and platforms, in addition to working with the Process Excellence group to resolve any ambiguities and inconsistencies in interpretations of standard processes and forms and implements a consistent approach across the team, provides input to process updates and recommends the development of new processes as needed.

 

Responsibilities:

 

• Develops and updates work practices and activities for the department as needed and oversees the implementation of new systems.
• Works with the system implementation group to help identify the business rules for the SCT group with new systems.
• Works with the training group to identify and develop competency-based training and task-specific training for the group.
• Assesses resource forecast and allocation across the portfolios and is responsible for proactive interviewing, hiring, onboarding, and assignment of peer partners for the group, as well as supervising the onboarding process.
• Responsible for developing and promoting talent within the group.
• Responsible for implementing an SCT best practice forum to provide training and updates to processes on a timely basis, as well as to identify areas for implementation of efficiencies.
• Oversight over the completion of the designated tasks to the SCT group members by trial teams to ensure execution per expectations.
• Serve as the point of escalation for the SCT group in case of challenges in project activities and help negotiate resolutions with stakeholders.
• Provides and mentors the SCT group on ICH-GCP and other regulations to ensure the group is current in clinical development and industry best practices.
• Interact with other key functions to ensure the group has the tools required to execute job responsibilities efficiently.
• Balances assignments and workload across the group, identifies Subject Matter Experts within the group on the core activities and systems to help onboard new members and provide training to the group and others as needed.
• Provide SCT guidance and support during internal audits, vendor audits and hosting inspections.
• Support adherence to the regulatory requirements, the ICH-GCP guidelines and the respective procedures (i.e. policies, SOPs, instructions) to help ensure team inspection readiness.

 

Requirements:

 

• A Bachelor’s degree in the life sciences or a university degree in a related field with experience in a medical profession. Advanced degree preferred.
• PMP or equivalent certification desirable.
• Minimum 12+ years of experience in pharmaceutical/biotech or related industry with 8+ years in global clinical development operations and 8+ years of direct line management, preferably including standardizing job responsibilities and developing work practices and guidance for a functional group.
• Directly involved in addressing regulatory inspections or internal process audits with their team.
• Advanced skills in Microsoft Office programs (Word, Excel, PowerPoint, MS Project). ·
• Knowledgeable of electronic data systems and working practices with technical solutions and implementation such as eTMF, LMS, CTMS, etc.

 

 

We offer: 

• A modern and employee-oriented corporate and management culture
• Team spirit and a work environment in which you will feel