Senior Clinical Trial Manager, FSP

Work Schedule

Environmental Conditions

Job Description

Job Description

At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of life-changing therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.

Summarized Purpose:

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. Interprets data on complex issues and makes good business decisions with support from line management. Works to ensure that all clinical deliverables meet the customers time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope through efficient management of the clinical team. Typically works independently on projects of moderate to high complexity and may assume regional lead or Clinical Study Manager responsibilities.

Key Responsibilities:

• Manages all clinical operational and quality aspects of allocated studies of moderate to high complexity in compliance with ICH accordance to project specific requirements may assume Lead CTM responsibilities on regional level Clinical Study Manager (CSM) responsibilities or take on additional responsibilities; e.g. process improvements manage complex programs have wider management or project coordination responsibilities.
• Ensure efficient and thorough study start-up by overseeing the Clinical team of the CROs and working closely with other relevant team members involved in the study set up (DM Reg CMC etc): ensure feasibility report are exhaustive Review site feasibility reports as per oversight plan support the CPM in site selection verify timely collection of essential study documents such as regulatory and ethics committee documents for submission and by controlling that all set up activities are performed prior to each site initiation as per the oversight plan.
• Support and ensure that all specific EDC system tasks under the clinical responsibility are completed and achieved according to the defined timelines without jeopardising the start of a trial.
• Support the Clinical CRO in the training of the CRAs on all study specific operational activities and participate in the organisation and preparation of the monitor and investigator meetings in collaboration with the other study team members (Corporate and/or affiliates CROs as appropriate)
• Customize site Key Risk/Performance Indicator template and follow these KRIs/KPIs at frequency agreed in the oversight plan
• Validate the final clinical study documents (such as study manual monitoring plan ) prepared by the Clinical CRO.
• Develops clinical tools (e.g. Monitoring Plan Monitoring Guidelines) in conjunction with the Data Quality Plan. Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensures 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. Collaborates with the project manager to prepare organize and present at client meetings including bid defense and hand-off meetings.
• Collaborates with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicates with the team and leads 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.
• Ensures 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 monitors clinical trials to assess performance and ensure contractual obligations are met. May routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
• May coordinate all start-up activities and ensures that essential document quality meets the expectation of Regulatory Compliance Review. Ensures timely regulatory submissions (if appropriate) are addressed. Reviews and follows up on all questions raised by ethics committees. Responsibilities may vary based on project timelines.
• Provides 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.
• In North America where assigned to GPHS (Government & Public Health Studies) projects may have limited line management responsibilities

Communicates with study sites regarding issues such as protocol patient participation case report form completion and other study-related issues

Knowledge Skills and Abilities:

• Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 5 years). 1 year of leadership responsibility
• MUST HAVE previous experience in both on site monitoring & in a CTM role
• Rare Disease Experience is HIGHLY preferred
• Travel: 40-50% Travel; US Travel
• Previous On Site Monitoring Experience
• Advanced mentoring/leadership/supervisory skills
• Excellent clinical trials monitoring skills; ideally remote AND onsite experience
• Demonstrated understanding of or ability to learn the companys SOPs WPDs and relevant regulations(e.g. ICH/GCP FDA guidelines)
• Strong organizational and negotiation skills
• Strong attention to detail
• Advanced written and oral communication skills
• Strong knowledge of English language and grammar
• Demonstrated use of computer to include data entry archival and retrieval
• Ability to travel as needed
• Excellent team player with team building skills
• Excellent interpersonal and conflict resolution skills
• Advanced ability to utilize problem-solving techniques applicable to constantly changing environment
• Solid knowledge of medical/therapeutic areas and medical terminology

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 100000 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 with PPD part of 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.