The Clinical Operations Manager oversees, trains, resources, coaches, and performance manages a team of clinical operations staff. The role focuses on achieving end results by using metrics and key performance indicators to drive performance, and acts as a point of escalation for performance concerns and training needs, ensuring adherence to company procedures. This position collaborates with the leadership team to address resourcing needs.
Responsibilities
Manage staff, providing coaching, mentorship, and work direction
Conduct regular performance appraisals and career discussions with staff, facilitating employee career development
Interview, recruit, and select staff
Manage and conduct induction/orientation programs for all new employees, ensuring their smooth assimilation into the company
Ensure all staff CVs, training records, position profiles, and experience profiles are complete and up-to-date
Ensure timeliness and accuracy of timesheets and expense reports
Support allocation activities per the local resourcing process
Support activities of project leads/functional leads to optimize the operational running of projects
Raise appropriately any issues which may impact project deliverables
Deliver training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements, and any other subjects that impact clinical operations
Identify training gaps and ensure that training requirements are met
May contribute to the development of training programs, where appropriate
Assure adherence to good ethical and regulatory standards
Alert management to quality issues, request QA audits as appropriate, and facilitate client and internal quality assurance audits as required
Handle and review systems (e.g., Activate, CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs, and general project status
Evaluate work of staff, including conducting PAVs (either remote or on-site) to thoroughly evaluate employee monitoring skills and project conduction when applicable
Participate in process improvement/development initiatives
Ensure understanding and facilitation of the risk-based monitoring approach
May provide input into bids and contribute to the procurement of new business where required
Collaborate with clinical operations senior management and executive staff on strategic planning and business development as required
May lead or contribute to initiatives that enhance the department's performance or lead to process improvement across the company
Requirements
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
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1+ year of leadership responsibility
Advanced mentoring/leadership/supervisory skills
Excellent clinical trials monitoring skills; Remote and on-site
Demonstrated understanding of or ability to learn the company’s SOPs, WPDs, and relevant regulations (e.g., ICH/GCP, FDA guidelines)
Demonstrated ability to evaluate medical research data
Strong organizational and negotiation skills
Strong attention to detail
Advanced written and oral communication skills
Good knowledge of English language and grammar
Demonstrated use of computer to include data entry, archival, and retrieval
Ability to travel as needed
Excellent teammate with team building skills
Excellent interpersonal and conflict resolution skills
Advanced ability to utilize problem-solving techniques applicable to a constantly changing environment
Solid knowledge of medical/therapeutic areas and medical terminology
Benefits
Global team that values passion, innovation, and a commitment to scientific excellence
Environment where collaboration and development are part of the everyday experience
Important Details
Schedule: Standard (Monday-Friday)
About the Company
The company has successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. When you join, you become part of a global team that values passion, innovation, and a commitment to scientific excellence.