Manages all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP.
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 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.
Education and Experience:
Degree in pharmacy, life science or related field.
Study management tasks experience.
FSP experience is ideal.
Knowledge, Skills and Abilities:
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
Excellent understanding and demonstrated application of GCPs and applicable SOPs.
Management of regulatory and/or IEC questions.
Development and preparation of the local informed consent form.
Effective oral and written communication skills, with the ability to communicate effectively with medical personnel.
Management of the delivery of study supplies.
Strong customer focus.
Effective interpersonal skills.
Strong attention to detail.
Effective organizational and time management skills.
Proven flexibility and adaptability.
Ability to work in a team or independently as required.
Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software.