CTM / Sr CTM Internal Medicine

Thermo Fisher Scientific Inc.; México; Remote; MXN 900,000 - 1,200,000; Full time

Job summary

Thermo Fisher Scientific Inc. is seeking a Sr Clinical Trial Manager to deliver final clinical data on time and within budget. You will oversee operational and quality aspects of studies of low to moderate complexity, and may assume CSM responsibilities on smaller projects as needed.

The role spans multiple therapeutic areas, requiring collaboration across project teams and external sites. Strong leadership, planning, and regulatory knowledge are essential for success in a dynamic, global

Qualifications

• Bachelor's degree or equivalent and relevant professional qualification.
• 5+ years of experience in clinical trial management or a related role.

Responsibilities

• Manage clinical operations and ensure quality for allocated studies in line with ICH GCP.
• Develop clinical tools and contribute to the Master Action Plan for clinical documentation.
• Collaborate with cross-functional teams, lead meetings, and ensure timelines and budgets are met.
• Monitor timelines, metrics, and CRF collection; participate in site communications and regulatory submissions as needed.
• Coordinate start-up activities and ensure ethics/regulatory submissions are timely.

Skills

Leadership

Planning

Communication

Team coordination

ICH/GCP knowledge

Education

Bachelor's degree

Tools

Outlook

Excel

Word

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Join Us as a Sr 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. The position involves working on projects of low to moderate complexity and as part of a team of CTMs.

The therapeutic scope includes Cardiovascular & Internal Medicine- Nephrology, Dermatology, GI, (UC/CD, EOE, EE), Cardiovascular, Liver, Immunology, Rare Disease, Diabetes, Obesity, Dyslipidemia, Women's Health, Rheumatology, (RA, SLE, Gout), Cell and Gene Therapy, CAR-T in Autoimmune.

Nephrology: (CKD, Delayed Graft Function, Antibody-Mediated Rejection, IgA Nephropathy, Lupus Nephritis)

Dermatology: Atopic Dermatitis, Psoriasis, Hidradenitis Suppurativa (HS), Prurigo Nodularis, Rosacea, Vitiligo, Alopecia Areata

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 Requirements:

• Bachelor's 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. You'll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.