Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards

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.

• Provides oversight and coordination of client portfolio for high value or pivotal client account studies. Provides oversight to internal departments and external clients to ensure the project requirements are understood, agreed and followed at all times, this requires negotiating and real-time decision making with the client. Facilitates the flow of technical and clinical laboratory information to all partners (investigational sites, sponsors, and non-technical personnel). Consults and uses, where appropriate, the scientific input of laboratory management and technical staff to assist the client with management of the clinical trial.
• Prepares the study specifications documents and follows the preparation according to budgets and contracts. Maintains at all times an updated study master file with version controls for specs, budgets and contracts. Ensures sponsors have authorized and signed off most recent versions of all docs and that a contract exists prior to deliver any services. Assures compliance with FDA and Good Clinical Practice guidelines, PPD SOPs, personnel policies and procedures, PPD Exposure Control Plan and applicable regulations regarding the transport of biological specimens.
• Consults with internal groups and support staff regarding procedural and budgetary items and the necessity for change due to any subsequent protocol amendments during initial review of protocol. Obtains other functions' commitment to close gaps and address issues timely and effectively. Serves as chief liaison between sponsor and all PPD internal departments performing the required tasks during all study phases. Educates Investigator sites by delivering a protocol specific lab procedures presentation and demonstration during an investigator meeting. Controls, manages and follows day to day activities during the course of the clinical trial to resolve any issues and answer queries. Actively consults with IT and data management development groups in the design, validation and implementation of new software and functionalities pertinent to project management activities.
• Consults with BD and finance staff during initial protocol review on standard services and costs, supporting RFP feasibility assessments. Advises on possible solutions if needed. Drafts responses for proposals.
• Prepares accurate invoices and coordinates with AD of finance for all billing/invoicing for the client's portfolio of projects

• 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 8+ years') or equivalent combination of education, training, & experience.

• Knowledge and proficiency in analytical chemistry technologies as well business acumen
• Knowledge and understanding of all aspects of lab study project management to include the areas of stability, QC and method development and validation
• Excellent problem solving, judgment and decision-making skills.
• Strong verbal, written and presentation skills
• Proven organizational and negotiation skills
• Extensive knowledge and proven leadership in project management
• Understanding of basic budgeting and forecasting terms and definitions
• Superior time management, planning, and organizational skills
• Full understanding of laboratory requirements, ICH guidelines, USP requirements and FDA guidance
• Ability to multitask and effectively prioritize workload
• Ability to work effectively with multi-level teams
• Ability to work in a fast-paced undefined environment
• Strong client relationship management skills

• 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.)