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Job Description
At Thermo Fisher Scientific, you’ll 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 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 development of novel frameworks for clinical research through our PPD 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.
Our non-interventional Peri and Post Approval Research Operations group consists of colleagues with knowledge, broad and in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays and complete high-quality, cost-efficient clinical studies.
As a Senior Clinical Team Manager (CTM), you combine knowledge, therapeutic expertise, and robust tools to help our clients deliver life-changing therapies to market. You take ownership, anticipate problems, find solutions and deliver results!
Summarized Purpose:
Responsible for achieving the final clinical deliverable (usually clean data from invaluable sources as per study protocol) within the time period specified in the contract with the customer. Interprets data on complex issues and makes business decisions with support from line management. 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. Typically works independently on projects of moderate to high complexity and may assume regional lead or Clinical Study Manager responsibilities.
Essential Functions:
- Manages all operational and quality aspects of allocated projects, in compliance with ICH GCP or GPP as specified. In accordance with project requirements, may assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or tackle additional responsibilities; e.g. process improvements, lead complex programs, have wider management or project coordination responsibilities.
- 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 handling CRF collection and query resolution. Continuously monitors projects to assess performance and ensure contractual obligations are met. May conduct Accompanied Field Visits(AFVs) and will be accountable for project financials.
- Communicates 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 essential document quality meets the expectation of Regulatory Compliance Review. Ensures timely regulatory submissions are addressed. Reviews and follows up on all questions raised by ethics committees. Responsibilities may vary based on specific project requirements.
- 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.
Education and Experience:
- 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.
- Experience in non-interventional research is preferred but will consider exceptional candidates.
Knowledge, Skills and Abilities:
- Strong leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
- Strong planning 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
- Proven understanding of organizational change principles
- Comprehensive understanding of the practices, processes, and requirements of clinical monitoring
- Strong judgment, decision making, escalation, and risk leadership 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 knowledge of budgeting, forecasting and fiscal management
- Strong attention to detail
- In-depth understanding of regulations e.g. ICH/GCP, FDA guidelines, etc.
- Strong digital literacy to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.
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 word's most urgent health needs, submit your application - we'd love to hear from you!
