Director Clinical Operations, Clinical Project Managers

We are seeking a highly motivated Director Clinical Operations to lead the development and implementation of the cFSP Clinical Project Management team. This individual will be a dynamic leader, comfortable working in a fast-paced and ambiguous environment, with the agility and capability to build high-performing teams from the ground up.

Direct and manage an assigned Clinical Project Management staff, who manage or support complex studies and/or programs to ensure delivery, time and quality resulting in strong financial performance and customer satisfaction. Manage direct reports and/or specificaccounts/portfolios and teams in accordance with organization's policies, applicable regulations and strategic decisions. Ensure direct report employees are fully trained, individual development is aligned and in place to meet project and organizational needs. Able to attract, develop and retain talent.

This role is more focused on team leadership and operational oversight rather than direct project delivery

Essential Functions
• Lead the design and establish the function.
• Identify opportunities to try new approaches; develop tools and frameworks.
• Apply strong problem-solving skills to navigate the challenges of building a new function.
• Foster a collaborative and communicative team culture.
• Bring alignment across the various stakeholders.
• Operate with agility, adapting quickly to change and guiding the team to do the same.
• Strong communication skills to help drive the vision.
• Build and mentor the team, promoting continuous learning and development.

• Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work, appraising performance and guiding professional development, rewarding and disciplining employees, addressing employee relations issues and resolving problems. Approve actions on human resources matters.;
• Work with individual staff to make sure all study management and project deliverables are completed as per the contract, to achieve quality deliverables on time and within budget and in accordance with SOPs, policies and practices. As their first point of contact, provide effective and timely consultation/guidance to employees on issue resolution.;
• Coach and mentor employees around project planning, project review, risk management and problem solving to ensure global alignment of work practices across the team through the adoption and use of all process and technology tools and improvements by employees.;
• Obtain and provide regular feedback to employees from other project team members and key stakeholders to assist in personal and professional development. May attend project team meeting in order to support development needs. Identify skill an competency gaps at the individual level and work to craft development plans that will close the gaps.;
• Ensure direct reports demonstrate working knowledge of EAC, baseline and change control in terms of scope, budget, schedule and risk/issue management.;
• Train the Project Lead management team on process and procedures. Ensure required trainings are completed on time.
• Complete and discuss the Project Lead competency framework with each direct report.
• Actively engage with the review of project performance dashboard for tracked information. Follow up with direct reports to ensure system and metrics compliance.;
• Review metrics and ensure required updates are made in IQVIA systems to ensure accurate and timely reporting is available to senior management
• Proactively manage risks linked to resourcing, project and/or individual needs with other management and leadership team members to manage study sues and obstacles.
• Work with individual staff to identify any quality issues within the study and provide coaching on resolution of issues, including implementation of corrective and preventative action plans and escalation.
• Provide technical expertise and/or clinical project management experience to assigned staff for training and process improvement efforts.
• Lead and/or actively participate in corporate initiatives, act as a departmental cross-functional liaison and/or change agent, provide technical expertise and project management experience.

Qualifications

• Bachelor’s degree in Life Sciences or related field.

• ~12+ years of relevant experience, including leadership in clinical project management, line management and operational oversight

• Mandatory to have experience working in FSP model 

• Strong knowledge of clinical trials, GCP/ICH, and the clinical research environment.

• Proven people leadership in global settings, with strong coaching and talent development skills.

• Excellent communication, stakeholder management, and problem-solving abilities.

• Agile, strategic thinker with strong organizational and decision-making skills.

• Proficiency in MS Office and project management systems.