Thermo Fisher / PPD
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
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.
Location/Division Specific Information
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
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
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 team of 125,000+ 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.
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.