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

Work Schedule reputed company (Mon-Fri) Environmental Conditions Office Job reputed company Join Us as a Clinical Team Manager (CTM) - reputed company an reputed company at the Forefront of Innovation The therapeutic scope includes Internal Medicine- Dermatology, 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. The Clinical Team Manager (CTM) is accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) reputed company the time period specified in the contract with the customer. Interprets data on reputed company issues and makes good business reputed company with support from line management. The role involves working to ensure that reputed company clinical deliverables meet the customer's time/reputed company/cost expectations, and maintaining profitability by ensuring clinical activity is conducted reputed company contract scope, through efficient management of the clinical team. Typically, the Senior Clinical Trial Manager works independently on reputed company of moderate to high complexity and may assume regional reputed company or Clinical Study Manager responsibilities. What You'll Do: 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. Education & Experience Requirements: 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. Preferred therapeutic experience: Dermatology, 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. Knowledge, Skills, Abilities: 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. Working Conditions and Environment: 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. Our 4i Values: reputed company – Innovation – Intensity – Involvement If you reputed company with our 4i values above and ultimately wish to accelerate the delivery of   reputed company and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you! Why Join Us? reputed company you join reputed company, you become part of a global team that values passion, innovation, and a commitment to scientific reputed company. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly reputed company a difference. Apply today to help us deliver reputed company’s breakthroughs. Apply To This Job