Trial Contracts Senior

Work Schedule

Environmental Conditions

Job Description

Join Us as a Contract Manager Make an Impact at the Forefront of Innovation

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 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.

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs spanning 2700 clinical trials across 100 countries in the last 5 years.

The Contract Manager leads the preparation negotiation and finalization of contracts process with an assigned workload of sites. Liaises and establishes effective relationships with clients and internal functional teams as directed by leadership. Ensures quality objectivity and risk analysis in the efficient delivery of contract templates process and negotiation parameters. Serves as lead for internal and external clients.

Essential Functions:

Drafts reviews negotiates and finalizes agreements with study sites in accordance with local/accepted process.
Negotiates within approved parameters both investigator grant budget negotiation parameters contractual terms and conditions in accordance with company contractual considerations client contractual considerations established process with sites and follows established escalation routes.
Communicates trains and provides approved contract templates process and negotiation parameters and client expectations to assigned teams.
Ensures collaboration quality alignment with terms and conditions process and client expectations with assigned team members.
Identifies and assesses legal financial and operational risks in accordance with approved company and client contractual considerations.
Acts as a lead regional interface and escalation contact with external clients for term & condition revisions outside of approved negotiation parameters client expectations and process deviations.
Provides recommendations and alternative resolutions contracts negotiations to internal and external clients.
Works with internal functional departments to facilitate coordination of different site startup activities impacted by contractual activities upon mutually agreed upon timelines.
Completes tracking and reporting as required.
Contributes to change initiatives within the department.
Completes periodic quality reviews and peer feedback reports.
May assist with training material preparation or delivery of training to team members.

Job Complexity: Management

Job Knowledge:

Administers and executes policies processes and procedures that affect subordinate employees and the workflow of the unit. Requires full knowledge of own area of functional responsibility.

Supervision Received:

Directly supervises individual contributors administrative support and / or entry-level professionals.

Business Relationships:

Assignments are task or activity oriented. Work is reviewed for soundness of judgment and overall quality and efficiency. A portion of the time may be spent performing individual tasks.

Education and Experience Requirements:
Bachelors degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 8 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:

Demonstrated understanding of regional principles of contract law including a general understanding of laws that influence contract language such as business intellectual property and local tax and stamp laws
Demonstrated ability to apply basic principles of investigator grant negotiation
General understanding of business contractual and financial principles that related to service agreements
Effective communication skills (verbal & written) in English and in language spoken at your local place of work
Capable of drafting and negotiating contract provisions and budgetary issues within parameters
Demonstrated ability to attention to detail
Excellent analytical and decision based thinking skills
Demonstrated depth of knowledge and expertise in clinical drug development and trial process attained within the pharmaceutical and/or CRO industry
Able to work independently or in a team environment
Excellent organizational and time management skills
Working knowledge of PPD SOP & WPDs
Able to organize competing priorities logically and review outstanding contractual risk and issues
Ability to demonstrate a customer focused style of communication problem solving and collaboration
Able to effectively use automated systems and computer applications
Flexible and able to multitask and prioritize competing demands/workload

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:

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.

Why join us
When you join Thermo Fisher Scientific you become part of a global team that values passion innovation and a commitment to scientific excellence. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.