Sr. Clinical Trial Manager

Job Description

Job Summary:

• Global Sr CTM is 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 complex issues and makes good 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 Product, 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.

Responsibilities:

• Manages all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP.
• In accordance to project specific requirements, may assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities; e.g. process improvements, manage 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 another protocol specific documents as required.
• Collaborates with the project manager to prepare, organize, and present at client meetings, including biodefense 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 lead steam 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 clinical trials to assess performance and ensure contractual obligations are met.
• May routinely conduct Accompanied Field Visits(AFVs) and 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 (if appropriate) are addressed.
• Reviews and follows up on all questions raised by ethics committees.
• Responsibilities may vary based on project timelines.
• 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.
• In North America, where assigned to GPHS (Government & Public Health Studies) projects, may have limited line management responsibilities.

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 8+ years).

Knowledge, Skills and Abilities:

• Strong leadership skills, effective at mentoring and training, and capable of motivating and integrating teams.
• Strong planning and organizational 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.
• Solid understanding of change management principles.
• Comprehensive understanding of the practices, processes, and requirements of clinical monitoring.
• Strong judgment, decision making, escalation, and risk management skills.
• Effective oral and written communication skills, including English language proficiency.
• Capable of evaluating own and team members workload products project budget and adjust resources accordingly.
• Strong financial acumen and knowledge of budgeting, forecasting and fiscal management.
• Strong attention to detail.
• In-depth understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
• Strong computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
• Capable of independently managing clinical only studies.