• Thermo Fisher Scientific
  • $124,570.00 -187,980.00/year*
  • Portsmouth , RI
  • Executive Management
  • Full-Time
  • 67 Orchard View Rd


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When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals., At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.

Director of Clinical Trials
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Job ID :
93772BR
Location :
US - New Hampshire - Portsmouth
:
Job Description
When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.
How will you make an impact?
As a member of the Anatomical Pathology Clinical management team, the Director of Clinical Operations will report directly to the VP of Global RAQA and provide leadership, project management, and program oversight to plan, conducting one or more high quality clinical trials concurrently in accordance with CFR, EMA, and ICH GCP regulations in support of regulatory authority submissions. The Director will manage all operational aspects of clinical trial projects.
What will you do?
* Responsible and accountable for the conduct of clinical trials.
* Oversee, lead, and manage cross-functional team resources and external service providers (including clinical operations, CRO, medical monitoring, safety, data management, auditors, and consultants) to conduct trials on time, on budget, in compliance, and of highest quality.
* Coordination/execution of all operational aspects of clinical studies (including identification and management of vendors, availability of clinical supplies at the sites, review and approval of request for investigational test articles).
* Work collaboratively with cross functional internal and external teams including regulatory affairs, medical writing and biostatistics
* Identify, qualify, audit, and manage all external vendors, including CROs. Take initiative to continually monitor each external vendor in performance management, escalate issues where appropriate, and make the appropriate changes in order to ensure trial conduct is completed in compliance and meets company's business objectives.
* Establish and ensure clinical trial team and clinical trial sites are properly trained and in compliance protocols, drive site selection, and patient recruitment programs that deliver enrollment targets. Performs site monitoring with field team, as needed.
* Facilitates all start-up activities including but not limited to investigational site contracts, investigational site, and ethics committee submissions.
* Facilitate confidentiality agreements, negotiate study agreements and budgets with sites and external vendors.
* Responsible for writing, reviewing, and/or approving clinical project deliverables
* Assist with the development of presentations, handouts, and coordination of Investigator Meetings.
* Drive site selection and patient recruitment programs that deliver enrollment targets.
* Responsible for ensuring the trial is \"audit ready\" at all times.
* Work with appropriate team members to ensure that all related documentation is current, on-file at respective site, CRO, and sponsor locations throughout trial conduct. Notify and prepare team for regulatory agency audit and address any audit observations appropriately and in a timely manner.
* Performs oversight of trial to ensure that safety concerns and/or adverse events/SAEs are properly tracked and reported.
* Manages each project within agreed upon timelines.
* Proactively monitors and reports trial progress and performance, timelines, and financial metrics on an ongoing basis to management team, including current status of study milestones and forecast budgetary requirements based on scope of work.
Other Responsibilities:
* Assist VP of RAQA and Clinical in leveraging technology solutions that support clinical trials operations and allow for visibility into trial quality and risk management
* Assist VP of RAQA and Clinical in development of appropriate SOPs, and other template documents for standardization of processes to ensure quality
How will you get here?
Education
* Advanced degree, or BS degree in science, nursing, health or related field
Experience
* Minimum of 10 years of clinical research and/or clinical project management experience in domestic and international clinical trials.
Knowledge, Skills, Abilities
* Excellent working knowledge of ICH GCP guidelines, CFR, EMA, and HIPAA regulations.
* Able to work independently and make appropriate strategic decisions to operationalize and move the clinical trials forward.
* Excellent written and oral communication and presentation skills
* The ability to manage multiple priorities, while maintaining attention to detail is critical.
* Experience operating effectively within a matrixed environment, specifically in a healthcare start-up setting.
* Ability to prioritize tasks and resources, meet deadlines, and be flexible to changing priorities.
* Possess strong and influential leadership skills with proven ability to lead internal and external team members at all levels.
* Computer skills should include routine business software and trial platforms: e.g., Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook.
* Must be willing to travel 25%.
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.
If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.
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.
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* Advanced degree, or BS degree in science, nursing, health or related field, * Minimum of 10 years of clinical research and/or clinical project management experience in domestic and international clinical trials. Knowledge, Skills, Abilities * Excellent working knowledge of ICH GCP guidelines, CFR, EMA, and HIPAA regulations. * Able to work independently and make appropriate strategic decisions to operationalize and move the clinical trials forward. * Excellent written and oral communication and presentation skills * The ability to manage multiple priorities, while maintaining attention to detail is critical. * Experience operating effectively within a matrixed environment, specifically in a healthcare start-up setting. * Ability to prioritize tasks and resources, meet deadlines, and be flexible to changing priorities. * Possess strong and influential leadership skills with proven ability to lead internal and external team members at all levels. * Computer skills should include routine business software and trial platforms: e.g., Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook. * Must be willing to travel 25%.


Associated topics: administrative assistant, administrative officer, administrative support, assist, operational assistant, operational support, operations director, records management, staff, support

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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