FSP Associate CTM

At Thermo Fisher Scientificyoulldiscover 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 healthiercleanerand safer. We provide our teams with the resources needed to achieve individual career goals while taking science a stepbeyond throughresearchdevelopmentand 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 valuable patients as specified in the study protocol) within thetime periodspecified in the contract with the customer. Interprets data on project issues and makes good business decisions with support from expert team members or linemanager. 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 on projects of low to moderate complexity and as part of a team of CTMs.

Key responsibilities:

• Manages all clinical operational and quality aspects ofallocatedstudies of low to moderate complexity in compliance with ICH accordancetoproject specific requirements may assume Clinical Study Manager (CSM) responsibilities on small and/or less sophisticated projects.

• Develops clinical tools (e.g.Supervising 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. Ensurestimelyset up organizationcontentand quality of the relevant sections of the Trial Master File (local and central). Mayparticipatein the design and development of CRFs CRF guidelines patient informed consenttemplatesand other protocol specific documents as the need arises. 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 aremaintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for thetimelyarchiving of documents and study materials for the department.

• Ensures achievement of the final clinical deliverable within the contractual time period specified by preparing and supervising clinical activity timelines and metrics providing status updates to the project manager regularly reviewing projects using tracking and management tools implementing recovery actions reviewing supervising visit reports and managing CRF collection and query resolution. Continuouslymonitorsor co-monitors clinical trials to assess performance and ensure contractual obligations are smaller regionsmayroutinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.

• May connect with study sitesregardingissues such as protocol patient participation case report formcompletionand other study-related issues.

• May coordinate all start-up activities andensuresthattimelyethics committee and regulatory submissions (ifappropriate)are addressed. Ensures that crucial document quality meets the expectation ofRegulatoryCompliance Review. Reviews andfollowsup 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 clinicalresponsibilitiesand identification ofadditionalresource requirements.

Keys to Success

Education and Experience:

Bachelors degree or equivalent and relevant formal academic / vocational qualification

Previousexperience that provides the knowledge skills and abilities to perform the job (comparable to 5 years).

KnowledgeSkillsand Abilities:

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

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

• Solid interpersonal andproblem solvingskills to enable working in a multicultural matrix organization

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

• Familiarity with the practices processes and requirements of clinical monitoring

• Good judgment anddecision makingskills

• Effective oral and written communication skills including English languageproficiency

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

• Sound financial acumen and knowledge of budgetingforecastingand fiscal management

• Strong attention to detail

• Solid understanding of relevantregulationse.g.ICH/GCP FDA guidelines etc.

• Good digital literacy to effectively use automated systems and computerized applications such as Outlook Excel Word etc.

Benefits

We offer competitiveremuneration annual incentive plan bonus healthcare and a range of employee benefits.ThermoFisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!

Our Mission is to enable our customers to make the world healthiercleanerand 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 technologicalinnovationand support patients in need. #StartYourStory with PPD part of Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.

Apply today!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminateon the basis ofrace color religion sex sexual orientation gender identity national origin protected veteran statusdisabilityor any other legally protected status.

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