Manager, Clinical Operations

Work Schedule

Environmental Conditions

Job Description

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

Our Early Development team focuses on Phase I and IB trials which represent the first practical tests of a compound’s clinical relevance and commercial viability. They are the culmination of years or even decades of research. Moreover, they set the stage for subsequent studies that will ultimately determine your compound’s efficacy, safety and positive impact on patient’s lives.

Discover Impactful Work:

As a Manger, Clinical Operations, you will collaborate with executive leaders, business development and across functional departments to develop strategies and implementation plans for clinical operations initiatives. Participates in the develop of expansion plans across clinical research units. Key role to ensure that integrated sites are prioritized for Phase II-IV studies.

A Day in the Life:

• Plans and coordinates general activites across the clinical research units Works with Team Leadership in activities related to the clinical teams.
• Analyzes and evaluates the ongoing efforts of each department, including adequacy/quality within the clinic.
• Liaises with medical director during feasibility process to ensure all participant safety requirements are accounted for during the scheduling process.
• Manages internal and external communication and evaluates information vital to increase probability of study award and to meet client deliverables.
• Works with management to offer training to clinical team members for an overall awareness of study placement.
• Leads cross-functional initiatives that will increase efficiencies of complex processes. Participates in business optimization workstreams.
• Role will manage and respond to feasibility surveys, attend/participate in bid defense meetings, and identify awarded studies where integrated sites can participate.

Keys to Success:

Education

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Experience

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

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, Abilities

• Expert knowledge of relevant regulations, e.g. ICH/GCP, FDA guidelines, etc.
• Strong organizational skills
• Performance management abilities
• Excellent judgment and decision making skills
• Effective oral and written communication skills
• Strong interpersonal skills and problem solving ability
• Time management skills
• Attention to detail
• Good computer skills including Microsoft Office
• Ability to motivate and integrate teams and teach/mentor team members
• Ability to communicate moderately complex 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.
• 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.

Physical Requirements / Work Environment

• Work is performed in an office and/or a clinical environment with exposure to electrical office equipment.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Occasional drives to site locations, frequent domestic travel and rare international travel.
• Personal protective equipment required such as protective eyewear, garments and gloves.
• Exposure to fluctuating and/or extreme temperatures on rare occasions.
• Frequently vertical and /or stationary for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Frequent mobility required.
• Frequent bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

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!