Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
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.
Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.
The PPD FSP Solution:
PPD's Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customers key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality. We deploy the same top-tier talent in ALL engagement models. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.
Joining within our PPD FSP functional area, allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience.
Discover Impactful Work:
The Clinical Trial Lead (CTL) is a cross-functional leader with global accountability for all operational deliverables of clinical studies from Final Protocol Concept Sheet to Clinical Study Report (CSR) and applicable results disclosure. The CTL provides operational expertise, strategic insights, and cross-functional leadership that enables the delivery of assigned trials within quality standards, agreed upon timelines and budget, and in alignment with applicable SOPs and regulatory requirements.
Successful candidates have extensive experience driving global clinical trial operations in drug development phases I-IV, CRO oversight, feasibility, start-up, execution, and study closure. Successful candidates have a strategic operational mindset with the ability to connect people, processes, and insights. They have the curiosity to embrace innovative and data-driven solutions. They lead with humility, partner effectively, and motivate & empower cross-functional teams to deliver with excellence.
The CTL will work with limited supervision or direction and have the ability to coach junior team members. Important to have experience with atopic dermatitis (dermatology).
A day in the Life:
Accountable for delivery of global trials within agreed upon timelines and budget. Establish and/or validate/refine study timelines and budget leveraging internal & external benchmarks. Oversee cross-functional planning, track study progress, and proactively manage completion of trial deliverables and milestones.
Responsible for leading, guiding, and overseeing CROs and other vendors to ensure contractual obligations are met according to plan and metrics.
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.
Continuously monitors 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.
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.
Keys to Success:
Education
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Experience
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ 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 site monitoring
Important to have experience with atopic dermatitis (dermatology)
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 acumen 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
Travel availability 10%-20%
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
