Clinical Research Manager - Thermo Fisher Scientific

Work Schedule
Standard Office Hours (40/wk)

Environmental Conditions
Office

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.

Leads 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.

Essential Functions and Other Job Information:

• 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 set-up, 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.

Job Complexity: Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.

Job Knowledge: Developing professional expertise, applies company policies and procedures to resolve a variety of issues.

Supervision Received: Normally receives general instructions on routine work, detailed instructions on new projects or assignments. Exercises judgment within defined procedures and practices to determine appropriate action.

Business Relationships: Contacts are primarily internal to the company with infrequent external customer / vendor contact on routine matters. Builds productive internal / external working relationships

Qualifications:
Education and Experience: 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 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 and 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 multi-tasking 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

Management Role: No management responsibility

Working Conditions and 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 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.

• 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 15-20 lbs.

• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

• 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 multi-task.

• Regular and consistent attendance

Benefits Overview:

At PPD, a part of Thermo Fisher Scientific, we offer comprehensive benefits including medical, dental, vision, pharmacy, employee assistance program, wellness program options and more!

Other benefits include:

• 401k with matching contributions, life insurance, long term and short-term disability insurance, flexible medical and dependent care spending accounts.
• Work life balance programs including paid time off for vacation/sick time, paid holidays, floating holiday.
• Wellness benefits including health and wellness programs, fitness facility access or discount, health coaching and more.
• Education reimbursement and tuition assistance programs, professional development training, skills training, education loan repayment plan, dependent scholarship program and more.
• Employee appreciation events, service recognition awards, annual reviews, merit plans and bonus plans
• Community connections and activities including philanthropic engagement, volunteer service projects and more