Job Description

Work Schedule


Standard (Mon-Fri) Environmental Conditions


Office


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.

Summarized Purpose:


Manages, selects, trains, resources, coaches and performance management of respective staff, which may be inclusive of CAS, CS, CRAs, PAs, RSMs 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

Knowledge, Skills, Abilities

• 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-dat
• 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 evaluatethe 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.

Qualifications:

Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Must have 8+ years of experience in Onsite Monitoring as CRA
• Should have Strong experience in Client Management, Project Management, Study Plan, CAPA related activities.
• 2+ years of experience in managing a team. 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

Working Environment


Thermo Fisher Scientific values the health and wellbeing 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.
• Able to work in non-traditional work environments.
• Able 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 have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.
• This role requires independent travel up to XX%, inclusive of traveling in automobiles, airplanes, and trains.


Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need