Project Lead Project Manager (FSP)

Work Schedule

Environmental Conditions

Job Description

Join Us as a Project Lead/Project Manager - Make an Impact at the Forefront of Innovation. The Project Manager serves as the Project Lead and primary sponsor contact and is accountable for the overall delivery of the project (quality time cost) on behalf of the organization. Additionally the Project Manager establishes and communicates customer expectations to the project team and ensures that escalation pathways are adhered to internally and externally. The role involves leading the cross functional project team to meet or exceed deliverables.

As part of the Study Management Team (SMT) is accountable for the implementation and execution of study plans to support successful clinical trial delivery including the following:

• Responsible for the delivery of the cross-functional project (time cost quality) by working closely with Global trial and functional leads.
• Ensures escalation pathways adhered to internally and externally (Rules of Engagement communication pathways).
• On projects where the scope requires ensures clear delineation in responsibilities and communication pathways for secondary project leads (such as lead in a specific region lead for a specific vendor(s) or subset of delivery).
• Ensures financial stewardship at a trial level by demonstrating an intimate understanding of the contract resource alignment to budget management of Out-of-Scope activity drive the Con Mod process/negotiations and team execution to timelines.
• Establishes communicates and manages customer expectations to achieve optimal delivery during the project
• Drives Risk Identification and Issue Resolution at project level
• Ensures project team compliance with organization policies SOPs ICH- GCP regulatory and project specific requirements.
• Responsible for vendor management where required
• Ability to delegate and effectively prioritize own and workload of project team members in a frequently changing environment
• Effective oral and written communication and presentation skills
• Proactive solutions oriented and adaptable to changing priorities and situations
• Advanced therapeutic area knowledge and clinical development guidelines and directives
• Sound interpersonal and customer service skills including the ability to lead motivate and coordinate cross-functional project teams
• Ability to negotiate persuade and influence others including a cross-cultural awareness

Education & Experience Requirements:

B.A. or B. a scientific discipline.
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 8 years) with 2 years of project/trial management.
Years of experience refers to typical years of related experience needed to gain the required knowledge skills and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge Skills Abilities:

Related scientific and clinical expertise and exceptional project-management risk-assessment contingency-planning and communication skills.
Extensive knowledge of clinical development related to one or more trial phases (I II III) as well as cross-functional drug development.
Expertise in Good Clinical Practices (GCP) International Council for Harmonization (ICH) guidelines and regulatory requirements for clinical development.
Ability to establish and execute operational plans.

Technical and systems competency such as computer skills to include effective use of systems and applications such as Microsoft Outlook Word Excel and PowerPoint as well as organization systems.
Ability to delegate and effectively prioritize own and workload of project team members in a frequently changing environment
Effective oral and written communication and presentation skills
Proactive solutions oriented and adaptable to changing priorities and situations

Preferred Skills & Credentials

An advanced degree in a related field.
Investigator site and/or monitoring experience.

Functional Service Provider (FSP) experience.

Prior neurology therapeutic experience required rare-disease experience also preferred

Ability to travel domestically and internationally

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

What Youll Do:

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 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 customers time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope through efficient management of the clinical team. Typically works on projects of low to moderate complexity and as part of a team of CTMs.

Essential Functions:
Manages all clinical operational and quality aspects of allocated studies of low to moderate complexity in compliance with ICH accordance to project specific requirements.
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 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.
Manages all aspects of monitoring operations and quality for assigned studies ensuring compliance with ICH GCP and applicable local regulations
Develops clinical tools and study plans collaborates with client CSO (to include but not limited to CCSLs) and leads team meetings to maintain timelines resources and quality. Serves as clinical subject matter expert for protocol and point of escalation for site manager as applicable
May include regional coordination with regional CMLs.
Ensures timely deliverables monitors trials communicates with study sites coordinates start-up activities addresses regulatory requirements and provides input on forecast estimates and resource management.
Completes trip report reviews in compliance with study plan timeline.
Issue escalation per plan responsible for identifying and reporting site performance issues trend analysis
May perform accompanied site visits with site manager and may attend meetings with Sponsor to discuss but not limited to country/region start up progress trending and issue identification/escalation and general site/country updates.
Generate monitoring plan and trip report completion annotations


Education and Experience:
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 5 years).
Monitoring or Study Management and Oversight Experience

Knowledge Skills and 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.

Preferred Skills & Credentials

An advanced degree in a related field.
Investigator site and/or monitoring experience.

Functional Service Provider (FSP) experience.

Prior neurology therapeutic experience required rare-disease experience also preferred

Working Conditions and Environment:
Work is performed in an office environment with exposure to electrical office equipment.
Ability to travel 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. 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.