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.
Education:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
Experience:
Previous experience in a similiar role that provides the knowledge, skills, and abilities to perform the job (comparable to 1-2+ 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 onsite monitoring.
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%.
