Sr. Clinical Team ManagerLead- Internal Medicine

Work Schedule

Environmental Conditions

Job Description

(Senior) Clinical Team Manager

Join Us as a Senior Clinical Trial Manager - Make an Impact at the Forefront of Innovation

The therapeutic scope includes Internal Medicine- Dermatology GI (UC/CD) Cardiovascular Liver Nephrology Immunology Rare Disease Diabetes Obesity Dyslipidemia Womens Health Rheumatology (RA SLE Gout) Cell & Gene Therapy and CAR-T in Autoimmune.

Desired location- West or Central region.

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

What Youll Do:

• Manage 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.
• 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 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.
• 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 clinical trials to assess performance and ensure contractual obligations are met. May routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
• 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 ensure that essential document quality meets the expectation of Regulatory Compliance Review. Ensure timely regulatory submissions (if appropriate) are addressed. Reviews and follows up on all questions raised by ethics committees. Responsibility may vary based on project timelines.
• 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 8 years). CTM and/or GCTM experience will be needed.
• 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.
• Preferred therapeutic experience: Dermatology GI (UC/CD) Cardiovascular Liver Nephrology Immunology Rare Disease Diabetes Obesity Dyslipidemia Womens Health Rheumatology (RA SLE Gout) Cell & Gene Therapy and CAR-T in Autoimmune.
• The team also prefers candidate that live in the West or Central region.

Knowledge Skills Abilities:

• Strong leadership skills effective at mentoring and training and capable of motivating and integrating teams.
• Strong planning and organizational skills to enable effective prioritization of workload and workload of team members
• Strong interpersonal and problem-solving skills to enable working in a multicultural matrix organization
• Solid understanding of change management principles
• Comprehensive understanding of the practices processes and requirements of clinical monitoring
• Strong judgment decision making escalation and risk management skills
• Effective oral and written communication skills including English language proficiency
• Capable of evaluating own and team members workload against project budget and adjust resources accordingly
• Strong financial acumen and knowledge of budgeting forecasting and fiscal management
• Strong attention to detail
• In-depth understanding of relevant regulations e.g. ICH/GCP FDA guidelines etc.
• Strong computer skills to effectively use automated systems and computerized applications such as Outlook Excel Word etc.
• Capable of independently managing clinical only studies.

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.

Our 4i Values:

• Integrity Innovation Intensity Involvement
• If you resonate with our 4i values above and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the worlds most urgent health needs submit your application wed love to hear from you!

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.

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:

• A choice of national medical and dental plans and a national vision plan including health incentive programs

• Employee assistance and family support programs including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short- and long-term disability in accordance with company policy

• Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan

• Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits please visit: Experience:

Manager