At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Location/Division Specific Information 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 project managers, clinical monitors, data managers, and regulatory experts, 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 an Associate Clinical Operations Manager you will oversee daily line management responsibilities of assigned team. This role will serve as positive leadership and professional role model for respective staff, which may be inclusive of CRAs, CTCs, RSMs and other clinical focused staff. Provides direct coaching and development support to operational teams. Ultimately responsible for effective resourcing, alignment, training and ongoing professional and technical development for staff. Collaborates with Clinical Management senior management and executive staff on strategic planning and business development as required. Primary focus on line and performance management of team members. Acts as point-of-escalation regarding performance concerns and training needs to ensure adherence to PPD 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 in any Life Science courses (Pharmacy, Nursing, Biology, and etc.

Experience

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 to 6 years of Clinical Research).
• 1+ year of leadership responsibility

Knowledge, Skills, Abilities

• Intermediate to 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

Physical Requirements / Work Environment Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others, relates sensitive information to diverse groups both internally & externally. Ability to apply basic principles to solve conceptual issues. Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Regular and consistent attendance. Benefits We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!