Clinical Team Manager

About the job

Environmental Conditions

Accountable for achieving the final clinical deliverable (usually clean data from valuable 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 expert 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.

Key responsibilities:

• 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 sophisticated projects.
• Develops clinical tools (e.g. Supervising 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 the need arises. Collaborates with the project manager to prepare organize and present at client meetings including bid defense and handoff 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 supervising clinical activity timelines and metrics providing status updates to the project manager regularly reviewing projects using tracking and management tools implementing recovery actions reviewing supervising visit reports and managing CRF collection and query resolution. Continuously monitors or comonitors 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 connect with study sites regarding issues such as protocol patient participation case report form completion and other studyrelated issues.
• May coordinate all startup activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed. Ensures that crucial 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 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).

Knowledge Skills and Abilities:

• Must have 5 years of Onsite Monitoring experience
• Must have additional 3 years of working experience as a Clinical Lead or Trial Manager
• Should have hands on working experience in managing multiple global clinical trials as lead
• Should have hands on working experience in Site Initiations Study Plan monitoring plan Budget Resource Managment and etc related activities
• Should have excellent Business communication skills
• 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 sophisticated/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 digital literacy to effectively use automated systems and computerized applications such as Outlook Excel Word etc.

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Remote Work :

No