• Job Description

  Req#: R-01196140

  Job Description

  As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

  What will you do?

  The primary role of this position is targeted toward clinical study planning, core team support, and CRO Management. In this role the primary responsibilities include:

  • Participate as Clinical Affairs representative to project core teams
  • Work closely with core team and Regulatory Representative during the study planning, coordination, and management phases
  • Document clinical study plans/ reports for inclusion into the project Design History File (DHF)
  • Manage all the aspects of clinical study execution on assigned projects (e.g., site qualifications, selections, visits, study monitoring, and TMF completion, etc.)
  • Facilitate internal and external clinical studies preparation and planning meetings
  • Interact as the primary interface between the company and CRO
  • Ensure that CRO activities and timelines are in coordination with regulatory and project requirements
  • Implement and document communication with CRO and study sites to ensure project progress
  • Real-time escalation of clinical study issues to Clinical Affairs Director and project core teams
  • Update Clinical Affairs procedures as needed
  • Manage direct reports as assigned
  • Mentor/ train junior level CRA personnel

  How will you get here?

  Education

  • Minimum Education Required: Bachelor's degree in Biology, Chemistry, bio-engineering or related science.
  • Certification as a Clinical Research Professional (CCRP) or equivalent is a plus (If certification is not in place, class work/ course work in Good Clinical Practices is required.)

  Experience

  • A Minimum of 4 years demonstrated experience managing in house and/or external clinical studies.
  • Minimum of 4 years working in the In Vitro Diagnostic or Medical Device Industry is preferred
  • Experience working with multi-functional project teams is required.
  • Computer literacy, including spreadsheet, database and word processing applications required.
  • Working knowledge of Good Clinical Practices is required.

  Knowledge, Skills, Abilities

  • Candidate must be an independent professional who proactively communicates frequently and effectively.
  • Must be comfortable working on projects where the project and its team members may be located at other sites.
  • Should be at ease with direct communication with internal project team members and external CROs.
  • Should be organized and able to work to on multiple projects with tight deadlines.
  • Willing to travel (10-15%).
  • Comfortable with ambiguity and change
  • High energy level; positive attitude; works well under stress; assertive and effective communicator.
  • Hands-on, action-oriented, and able to implement effectively.
  • Continuous improvement minded; familiar with balancing the need for quality and the need for efficiency
  • Able to work autonomously in a matrix-managed organization
  • Ability to provide solutions based on knowledge of clinical research and industry experience

  Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

  Apply today! http://jobs.thermofisher.com

  Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

  Accessibility/Disability Access

  Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

  *This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

  Compensation and Benefits

  The salary range estimated for this position based in California is $103,000.00–$137,500.00.

  This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

  • A choice of national medical and dental plans, and a national vision plan, including health incentive programs

  • Employee assistance and family support programs, including commuter benefits and tuition reimbursement

  • At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

  • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

  • Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

  For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

• About the company

  Thermo Fisher Scientific is an American provisioner of scientific instrumentation, reagents and consumables, and software and services to healthcare, life science, and other laboratories in academia, government, and industry.

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