Work Schedule

Standard (Mon-Fri)

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.

Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end 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 implement high-quality, cost-efficient clinical studies.

Discover Impactful Work:

Manages the preparation, discussion and finalization of the contracts process. Liaises and establishes effective relationships with sites and internal functional teams. Ensures quality, objectivity and risk analysis in the efficient delivery of Investigator Contracts. May mentor junior staff.

A day in the Life:Drafts, reviews, negotiates and finalizes agreements with study sites in accordance with local/accepted process.Negotiates within approved parameters both investigator grant budget consultation parameters, contractual terms and conditions in accordance with Company contractual considerations, client contractual considerations, established process with sites and follows established escalation routes.Ensures compliance to established mediation parameters, authority approval, contractual process and client expectations.Ensures compliance of budgetary guidance, templates and process.Identifies and assesses legal, financial and operational risks in accordance with company and client contractual considerations, and escalates to appropriate level of the organization per established processes.Provides recommendations and alternative resolutions to Investigator Contracts discussions through established escalation channels.Coordinates with internal functional departments to ensure various site startup activities are aligned with contractual activities and mutually agreed upon timelines; ensures alignment of contract dialogue process for sites and study are properly aligned to the critical path for site activation.Achieves target cycle times for site activations.Ensures guidelines and processes are followed for efficient escalation of out of parameter issues, as applicable.Completes tracking and reporting as required.May provide training and mentoring to junior staff.Participates in country process improvement initiatives, representing Global Site Contract activities within country team meetings.Acts as country subject matter expert in review of Investigator Contracts training materials.Liaises with Global Site Contracts to ensure full compliance with established global processes and corporate directives.Completes periodic quality reviews and peer feedback reports.May act as lead with amendment/novation client projects and oversight of confidentiality agreement negotiations.Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. This job is the fully qualified, dedicated, journey-level position.Normally receives little instruction on day-to-day work, general instructions on new assignments.Demonstrates good judgment in selecting methods and techniques for obtaining solutions.Represents the department as a prime contact on projects.Interacts with internal and external personnel on significant matters often requiring coordination between functional areas.Networks with senior internal and external personnel in own area of expertise.Keys to Success:

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

ExperiencePrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ 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

Detailed understanding of the principles of contract law, including a general understanding of laws that influence contract language, such as business, intellectual property and local tax and stamp lawsEffective communication skills (verbal & written) in English and local languageDetailed understanding and demonstrated ability to effectively mediate investigator grant budgets within parametersDemonstrated skill in strong attention to detailExcellent analytical and decision based thinking skillsSolid knowledge and understanding of the pharmaceutical product development process and involvement of CROsAble to work independently or in a team environmentGood organizational and time management skillsSolid understanding of PPD SOP & WPDsAble to organize competing priorities logically and review outstanding contractual risk and issuesAble to effectively use automated systems and computerized applicationsAbility to demonstrate a customer focused style of communication, problem solving and collaborationDetailed understanding of the principles of contract law, including a general understanding of laws that influence contract language, such as business, intellectual property and local tax and stamp lawsDetailed understanding and demonstrated ability to effectively negotiate investigator grant budgets within negotiation parametersDemonstrated ability to independently train and mentor staffDemonstrated ability to provide valuable feedback to Investigator AnalystsStrong problem solving skills that are demonstrated via solid risk analysis that results in resolution or escalation as appropriateDemonstrated ability to effectively negotiate Investigator Contracts in the best interests and position of the company and client

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.Ability 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 require travel. (Recruiter will provide more details.)