CTM Vaccines

at  Thermo Fisher Scientific

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 individual 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 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.

JOB DESCRIPTION:

Manages 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.

• 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 managing CRF collection and query resolution.
• 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.
• Ensures that essential document quality meets the expectation of Regulatory Compliance Review.
• Reviews 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:

Bachelor’s degree or equivalent and relevant formal academic / vocational qualification

EXPERIENCE:

A seasoned, experienced professional with strong background in clinical monitoring full understanding of area of specialization; resolves a wide range of issues in creative ways.
Must have experience in dealing with multi-centric complex clinical trials and have proven record of handling regional and global studies preferably with 3-5 years of clinical monitoring experience

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 foresight 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.
• Should have strong conflict leadership skills
  Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

• 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 managing CRF collection and query resolution.
• 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.
• Ensures that essential document quality meets the expectation of Regulatory Compliance Review.
• Reviews 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 requirement