Clinical Research Manager

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll 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 lifechanging 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 global Clinical Operations colleagues within our PPD clinical research services provide endtoend support for clinical trials from study start up to monitoring through to study close out across commercial and government contracts. Together we help clients define and develop clinical programs minimize delays and execute highquality costefficient clinical studies.

Discover Impactful Work:

Manages all aspects of assigned clinical trials involving patient and healthy subject populations in both inpatient and outpatient settings. Acts as liaison between functions (i.e. PM investigator research team etc. Ensures client requirements and specifications are communicated to the research teams and any issues/questions raised by the research team or investigators are communicated back to the project leads and client (as needed) for resolution.

A day in the Life:

• Serves as a primary point of contact for the project team and the business unit for clinical site related aspects of the study.
• Collaborates with internal departments to ensure deliverables are met as defined within the contract and study timeline.
• Manages all clinical and administrative aspects of a clinical project including sitelevel study setup recruitment conduction and data collection.
• Manages IRB submissions including creation of study specific informed consent forms SAE notifications and maintenance of the regulatory file and documents.
• Collects feedback from various departments to create a risk register for each study and maintains and updates the register throughout the study. Works with the Principal Investigator to ensure that a risk mitigation plan (RMP) is finalized and reviewed by the safety committee prior to study conduct.
• Works closely with finance department to manage fiscal aspects of study conduct while meeting sponsor requirements and adhering to the protocol SOPs and contract.
• Provides vendor oversight when services are contracted.

Keys to Success:

Education

Bachelors 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 2 years).

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

• Knowledge of Phase I processes and strong knowledge of clinical study operations
• Knowledge of FDA regulations and ICH GCP guidelines
• Solid computer skills with working knowledge of Microsoft Office applications
• Good time management and multitasking skills
• Solid written and verbal communication skills
• Strong organizational and prioritization skills with the ability to prioritize workload and adapt to changing study needs
• Favorable consulting skills with t to act as a liaison between external and internal groups
• Knowledge of budgeting/forecasting/planning projects

Physical Requirements / Work Environment

• Work is performed in an office/ laboratory and/or a clinical environment.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment.
• Personal protective equipment required such as protective eyewear garments and gloves.

Physical Requirements:

• Ability to work in an upright and /or stationary position for 68 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.
• Occasional crouching stooping with 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 1520 lbs.
• Ability to access and use a variety of computer software developed both inhouse and offtheshelf.
• Ability 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 to obtain or relate information to diverse groups.
• 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 multitask.
• 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 forwardthinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!