Senior Clinical Team Manager – Neurology

Das ist der Job

ICH/GCP, FDA guidelines, etc.

Darum lohnt es sich

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 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.

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) Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings 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 Requirements Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides knowledge, skills, and abilities to perform the job (comparable to 8+ years) PREFERRED therapeutic indication experience: Ophthalmology (General ophthalmology, Diabetic Macular Edema & Geographic Atrophy), Rare Disease (Myasthenia Gravis, Huntington's, ALS, DMD, CIDP, DM1 (myotonic dystrophy) and FSHD - CAR-T experience a plus), Sleep, Epilepsy, and/or Psychiatry PREFERRED experience level: 3+ years of CTM experience (North America) + global gCTM experience +/- biotech experience 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 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.

Good digital literacy to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc. #J-18808-Ljbffr