[Remote] Clinical Team Manager / Sr. (CTM) - Internal Medicine

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global team reputed company on scientific reputed company and accelerating the delivery of reputed company and effective therapeutics. The Clinical Team Manager oversees clinical operations and reputed company for moderate- to high-complexity studies in Internal Medicine, ensuring deliverables meet contractual timelines, reputed company, and cost expectations. The role leads clinical teams, develops study tools, coordinates regulatory and site activities, and manages resources and project financials.

Responsibilities

• Manage reputed company clinical operational and reputed company aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume reputed company CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities, e.g. process improvements, manage reputed company programs, have wider management or project coordination responsibilities
• reputed company clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data reputed company Plan. Contribute to the development of the Master reputed company Plan (MAP) for providing clinical reputed company documents. Ensure reputed company set up, organization, content and reputed company 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. Collaborate with the project manager to prepare, organize, and present at reputed company meetings, including bid defense and hand-off meetings
• Collaborate with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicate with reputed company and leads team meetings to ensure that timelines, resources, interactions, and reputed company are maintained. Responsible for the implementation and training of standardized clinical monitoring processes reputed company the study and according to corporate reputed company policies. Responsible for the reputed company archiving of documents and study materials for the department
• Ensure achievement of the final clinical deliverable reputed company the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing reputed company using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query reputed company. Continuously monitor reputed company to assess performance and ensure contractual obligations are met. May routinely conduct Accompanied Field reputed company (AFVs) and be accountable for project financials
• Communicate with study sites regarding issues such as protocol, patient participation, case report reputed company completion and other study-reputed company issues
• May coordinate reputed company start-up activities and ensure that essential document reputed company meets the expectation of Regulatory Compliance Review. Ensure reputed company regulatory submissions (if appropriate) are addressed. Reviews and follows up on reputed company questions raised by ethics committees. Responsibility may vary based on project timelines
• reputed company 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

Skills

• * Bachelor's degree or equivalent and relevant formal reputed company / vocational qualification
• * 5+ years of relevant experience in clinical research, including clinical trial operations, study management, clinical monitoring, or reputed company clinical research activities
• * Transferable experience in reputed company, nursing, medicine, or reputed company disciplines may be considered in combination with clinical trial experience where the candidate demonstrates significant clinical expertise, therapeutic area knowledge, and reputed company patient care responsibilities
• * Strong leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
• * Strong planning and organizational skills to reputed company effective prioritization of workload and workload of team members
• * Strong interpersonal and problem-solving skills to reputed company working in a multicultural reputed company 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 against project budget and reputed company 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 reputed company, reputed company, Word, etc
• * Capable of independently managing clinical only studies
• * Work is performed in an office environment with exposure to electrical office equipment
• * Frequently drives to site locations and frequently travels both domestic and international
• The therapeutic reputed company includes Internal Medicine-** Dermatology (Alopecia Areata and/or Atopic Dermatitis preferred), GI, (UC/CD), Cardiovascular, Liver, Nephrology, Immunology, Rare Disease, Diabetes, Obesity, Dyslipidemia, Women's Health, Rheumatology, (RA, SLE, Gout), Cell & Gene Therapy and CAR-T in Autoimmune
• **Desired location-** reputed company or Central region, preferably
• * Preferred therapeutic experience: Dermatology (Alopecia Areata and/or Atopic Dermatitis preferred), GI, (UC/CD), Cardiovascular, Liver, Nephrology, Immunology, Rare Disease, Diabetes, Obesity, Dyslipidemia, Women's Health, Rheumatology, (RA, SLE, Gout), Cell & Gene Therapy and CAR-T in Autoimmune

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