Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Mgr Clin Operations
Our Global Clinical Research team, who powers our PPD® clinical research portfolio, is our leading global contract research organization (CRO). We provide comprehensive, integrated drug development, laboratory and lifecycle management services. Our customers include pharmaceutical, biotechnology, medical device, academic and government organizations.
The Clinical Operations team at PPD, part of Thermo Fisher Scientific, is a dynamic group of professionals dedicated to managing and executing clinical trials with precision and efficiency. Comprised of experienced clinical operations managers, clinical monitors, clinical trial coordinators, regulatory experts, contract specialists, the team collaborates seamlessly to ensure trials are conducted ethically, in compliance with regulations, and deliver high-quality results. With a focus on patient-centricity and innovation, the Clinical Operations team plays a pivotal role in advancing healthcare through cutting-edge research.
Discover Impactful Work:
As a Clinical Operations Manager you will oversee daily line management responsibilities of assigned team - management, selection, training, resourcing, coaching and performance management of respective staff, which may be inclusive of CAS, CS, CRAs, CTCs and/or other clinical operations focused staff. Focuses on end results using metrics and key performance indicators to manage performance. May lead or contribute to initiatives that enhance the department's performance or lead to process improvement across the company. Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required. Acts as point-of-escalation regarding performance concerns and training needs to ensure adherence to the company's SOPs and WPDs. Works in collaboration with the leadership team for resourcing needs.
A day in the Life:
- Manages and conducts induction/orientation programs for all new employees, ensuring their smooth assimilation into the company.
- Ensures all staff CVs, training records, position profiles and experience profiles are complete and up-to-date.
- Supports allocation activities per the local resourcing process. Supports activities of project leads/functional leads to optimize the operational running of projects.
- Escalates appropriately any issues which may impact project deliverables.
- Delivers training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects that impact clinical operations. Identifies training gaps and ensures that training requirements are met.
- May contribute to development of training programs, where appropriate.
- Participates in process improvement/development initiatives.
- Ensures understanding and facilitation of the risk based monitoring approach.
- Alerts management to quality issues, requests QA audits as appropriate, and supports direct reports and project team in providing audit responses as required.
- Manages and reviews systems (e.g. CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs and general project status.
- Evaluates work of staff, including conducting PAVs (either remote or on-site) to thoroughly evaluate the employee monitoring skills and project conduction when applicable.
- Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.
Keys to Success:
Education
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
- 1+ year of leadership responsibility
Knowledge, Skills, Abilities
- 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 team player with team building skills
- Excellent interpersonal and conflict resolution skills
- Advanced ability to utilize problem-solving techniques applicable to constantly changing environment
- Solid knowledge of medical/therapeutic areas and medical terminology
PPD values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary for typical working hours.
- Ability to use and learn standard office equipment and technology with proficiency.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
- May require travel
What we offer:
At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.