Junior / Lower Mid-Level - Clinical Trial Manager

Katalyst CRO; Boston (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO in the United States seeks a seasoned Clinical Trial Manager to oversee operational and quality aspects of clinical studies. You will lead a team, ensure deliverables meet time/quality/cost expectations, and maintain profitability within contract scope.

You will collaborate with cross-functional teams, prepare monitoring plans, and manage feasibility, timelines, and documentation to support client engagements and successful trial closures.

Qualifications

• Strong leadership skills with experience mentoring and guiding teams.
• Excellent planning and organizational abilities for workload prioritization.
• Solid interpersonal and problem-solving skills in a matrix organization.
• Ability to adapt to changing environments with complex situations.
• Familiarity with clinical monitoring practices and regulatory requirements.
• Excellent written and verbal English communication.
• Ability to manage workload against project budget and adjust resources.

Responsibilities

• Manages all clinical operational and quality aspects of allocated studies, low to moderate complexity, in compliance with ICH GCP.
• Develops clinical tools and contributes to master action plans; ensures timely set up and quality of Trial Master File.
• Participates in design of CRFs and templates; collaborates with project manager for client meetings.
• Coordinates with clinical team and other departments to meet deliverables and leads team meetings.
• Implements standardized monitoring processes and monitors study timelines and metrics.
• Tracks activity timelines, provides status updates, and manages CRF collection and query resolution.
• Monitors or co-monitors trials; may conduct field visits and oversee project financials in smaller regions.
• Communicates with study sites on protocol issues, patient participation, and CRF completion.
• Coordinates start-up activities and ensures ethics committee and regulatory submissions as needed.

Skills

Leadership

Project management

People management

Communication

Budgeting

Regulatory knowledge

ICH/GCP familiarity

Education

Bachelor's degree or equivalent

5+ years of relevant experience

Job description

• 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 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 on projects of low to moderate complexity and as part of a team of CTMs.

Summarized Purpose

• 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 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 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 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.
• 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.

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.

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).