CTMSr CTM FSP

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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 customers time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope through efficient management of the clinical team. The position involves working on projects of low to moderate complexity and as part of a team of CTMs. This opportunity is an exciting prospect for a big pharma company and for a new division focused on Oncology/Cell therapy.

What Youll Do:
Manage all clinical operational and quality aspects of allocated studies of low to moderate complexity in compliance with ICH 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 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 Requirements:
Bachelors degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 5 years).

In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.

Knowledge Skills 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 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 acument and knowledge of budgeting forecasting and fiscal management
Strong attention to detail
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.

Working Conditions and 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.

Why Join Us

When you join Thermo Fisher Scientific you become part of a global team that values passion innovation and a commitment to scientific excellence. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthroughs.

Required Experience:

Senior IC

Employment Type : Full-Time
Experience: years
Vacancy: 1