Thermo Fisher Scientific

Clinical Trial Manager (FSP)

Thermo Fisher Scientific • $110K — $130K *
US-AnywhereRemote in Rhode Island, US
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree or equivalent in a relevant field.
  • 5+ years of experience in clinical trial management.
  • Experience within oncology is advantageous.
  • Familiar with Australia’s study start-up process and regulatory submissions.
  • Proven ability to manage multiple studies and competing priorities.

Responsibilities

  • Manage clinical operational and quality aspects of allocated studies.
  • Develop clinical monitoring tools in conjunction with the Data Quality Plan.
  • Collaborate with project managers for client meetings and presentations.
  • Lead team meetings to ensure project timelines and quality are maintained.
  • Implement standardized clinical monitoring processes and document archiving.
  • Monitor clinical trials for performance and compliance with contracts.
  • Coordinate start-up activities and ensure regulatory submissions are timely.

Benefits

  • Comprehensive health and wellbeing programs, including an Employee Assistance Program.
  • Flexible work arrangements for better work-life balance.
  • Generous leave policies including paid birthday leave and parental leave.
  • Paid volunteer time to support your preferred charities.
  • Access to online learning courses and mentorship for career development.
Full Job Description
Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Location/Division Specific Information

  • This is a home-based position and preferably based in central Sydney


About the Role:

Join Us as a Clinical Trial Manager - Make an Impact at the Forefront of Innovation

The Clinical Trial Manager is accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. The Clinical Trial Manager interprets data on project issues and makes good business decisions with support from experienced team members or line manager. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team.

What You'll Do:

  • Manage all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Clinical Study Manager (CSM) responsibilities on small and/or less complex projects.


  • Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan.


  • Contribute to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required.


  • Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.


  • Collaborate with the clinical team and other departments as needed to meet deliverables of the project.


  • Regularly communicate with the team and lead team meetings to ensure that timelines, resources, interactions, and quality are maintained.


  • Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department.


  • Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution.


  • Continuously monitor or co-monitors clinical trials to assess performance and ensure contractual obligations are met. In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.


  • May communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.


  • May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed. Ensure that essential document quality meets the expectation of Regulatory Compliance Review. Review and follows up on all questions raised by the ethics committees.


  • May provide input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.


Education

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


Experience

  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).


  • Experience within oncology will be consider advantageous


  • Study start-up experience within Australia will be considered an asset


  • Experience managing multiple studies and competing priorities simultaneously.


Knowledge, Skills, Abilities

Strong knowledge of the study start-up process in Australia, including regulatory submissions and the development and negotiation of investigator site contracts and budgets.

  • Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams


  • Agile, flexible, and resourceful, with the ability to work efficiently in a fast-paced environment.


  • Good planning and organizational skills to enable effective prioritization of workload


  • Solid interpersonal and problem solving skills to enable working in a multicultural matrix organization


  • Capable of working effectively in a changing environment with complex/ambiguous situations


  • Familiarity with the practices, processes, and requirements of clinical monitoring


  • Good judgment and decision making skills


  • Effective oral and written communication skills, including English language proficiency


  • Capable of evaluating workload against project budget and adjusting resources accordingly


  • Sound financial acumen and knowledge of budgeting, forecasting and fiscal management


  • Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.


  • Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.


Physical Requirements / Work Environment

  • Work is performed in an office environment with exposure to electrical office equipment.


  • Frequently drives to site locations and frequently travels both domestic and international.


Benefits

Join our team and take advantage of these great benefits! Apply now to learn more about the full range of benefits we offer.

  • Health & Wellbeing: Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.


  • Flexibility: Balance your work and personal life with flexible arrangements.


  • Extra Leave: Benefit from generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave.


  • Charitable Giving & Volunteering: Make an impact with paid volunteer time to support non-profit organizations that matter to you.


  • Learning & Development: Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.


Thermo Fisher Scientific Australia WGEA Employer of Choice for Gender Equality

About Thermo Fisher Scientific

Thermo Fisher Scientific Careers

Join the vibrant team at Thermo Fisher Scientific, a global leader in serving science and making the world healthier, cleaner, and safer. With a workforce of over 75,000 professionals, Thermo Fisher Scientific offers unparalleled job opportunities and a culture of innovation that propels your career to new heights. Work You’ll Do At Thermo Fisher Scientific, you will be part of a team that is dedicated to enabling our customers to make the world healthier. Whether you are involved in the development of life-saving drugs or innovative environmental solutions, your work will have a profound impact on society. Our commitment to leadership in the industry is unwavering. With Thermo Fisher Scientific, you will lead projects that set standards in scientific inquiry and market leadership. You will work at the intersection of science, technology, and industry expertise, driving digital innovation in every aspect of our business. Join our diverse team of professionals and engage in roles that span across various functions and disciplines. From research and development to marketing and sales, the breadth of job opportunities available means that you can find the perfect match for your skills and passions. Innovative Work As part of our team, you will have access to cutting-edge tools and technologies that foster creativity and innovation. Thermo Fisher Scientific is home to a dynamic range of career paths, all designed to challenge you and help you grow as a professional. Our employment philosophy emphasizes diversity and inclusivity, ensuring that all team members have the opportunity to thrive. We believe in nurturing talent through robust training programs, leadership development, and opportunities for career advancement. Be Part of a Great Team Working at Thermo Fisher Scientific means being part of a global network of enthusiastic, talented, and ambitious individuals. Our culture is built on collaboration, where each member’s unique skills and perspectives are valued. You will enjoy benefits that support both your professional growth and personal well-being. Future-Proof Your Career Embark on a journey of growth and continuous learning with Thermo Fisher Scientific. We offer a variety of training and development programs that cater to your interests and career goals. From internships for budding scientists to leadership training for aspiring executives, our programs are designed to equip you with the skills needed for a successful and fulfilling career. Explore Discover how our commitment to innovation leads to advancements in health and science: [Read More] Learn about our leadership in environmental sustainability and how you can contribute: [Read More] The Thermo Fisher Scientific Difference Our global presence and commitment to innovation mean that your work extends beyond borders and makes a tangible impact worldwide. The collaboration between our teams drives our leadership in the scientific community and contributes to a culture that embraces diversity and fosters professional growth. Stay Connected Join Our Team Search open positions that match your skills and interest. We are always on the lookout for passionate, curious, and driven team players. Explore our job opportunities and find out how you can contribute to our meaningful work. SEARCH THERMO FISHER SCIENTIFIC JOBS Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. READ CAREERS BLOG Job Alert Emails Customize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at Thermo Fisher Scientific.
Learn more about Thermo Fisher Scientific
Size
130,000 employees
Market Cap
$213.3 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.3 billion
Founded
1956
5 Year Trend
+16.5%
Revenue
$32.2 billion
NASDAQ
TMO
* Ladders Estimates

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