Note: The job is a remote job and is open to candidates in USA. Thermo Fisher Scientific is a global scientific services company supporting pharmaceutical and biotechnology organizations in clinical research and biopharmaceutical operations. The Program Manager I coordinates study setup, maintenance, closure, supply activities, communications, budgets, and deliverables while supporting Project Managers and clinical teams.
Responsibilities
- Serve as local study coverage for global studies and point of contact for Clinical teams. Ensure timely completion of study activities and deliverables. Document communication and actions with sponsors or investigator sites
- Manage existing Batch, Supply Only, and “In Conduct” studies. Develop new study set-ups as appropriate in collaboration with the Tech Ops group
- Serve as designated backup for PM staff (Centralized) and point of contact coverage for Project Managers when out of office. Review and prepare with Project Managers in advance of coverage
- Advise Project Managers on procedural and budgetary items and on the necessity for changes due to any subsequent study modifications and/or protocol amendments. Monitor monthly Budget-to-Burn reviews and contract modifications
- Support the Project Management group with development and implementation of initial study supply orders, including creation of initial supply templates and submission of initial shipment requests to the Supply Chain Management group
- Monitor completion of shipment requests
- Schedule group meetings and teleconferences (internal and external), prepare and distribute agendas, record and distribute minutes as required
- Monitor assignments and adjust priorities and work schedules to meet deadlines and provide high-quality deliverables. Complete additional tasks needed in support of project, client, and departmental objectives
Skills
- We welcome applicants from all locations within the US
- Must be legally authorized to work in the United States without sponsorship
- 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 0 to 2 years') or equivalent combination of education, training, & experience
- Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines
- Effective project management and organizational skills
- Good computer skills
- General knowledge of clinical trial processes and programs
- Strong attention to detail and problem solving skills
- Good written and verbal communication skills
- Ability to effectively conduct oral presentations
- Demonstrated experience in identification and resolution of technical problems in a professional environment
- Ability to maintain a high degree of confidentiality with clinical teams
- Ability to attain, maintain and apply a working knowledge of applicable procedural documents
- Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others
- Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment
- Exposure to biological fluids with potential exposure to infectious organisms
- Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste
- Personal protective equipment required such as protective eyewear, garments and gloves
- Exposure to fluctuating and/or extreme temperatures on rare occasions
- Occasional drives to site locations, occasional domestic travel
Benefits
- This is a fully remote role supporting our GMP Laboratory in Middleton, WI.
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