Clinical Trial Manager / Senior CTM - Oncology (Remote)

Description The Clinical Trial Manager (CTM) /Senior CTM is accountable for the operational and scientific reputed company, the set-up, execution and delivery of their assigned clinical trials at the regional/local level. this specific CTM role will be working in the Oncology TA. CTMs contribute to delivery of reputed company’s pipeline through accurate planning and efficient execution of trials that bring speed & value to participating patients and sites. The CTM provides leadership and direction to the R/OPU trial team for their responsible R/OPU and is accountable for the overall success and delivery of their assigned clinical trial/s according to defined milestones and key performance indicators. They are responsible for steering and directing clinical trial activities, including patient and site engagement activities, direct communication and interaction with multiple internal and external stakeholders (e.g., investigative sites) and trial team members at a regional/local and global level. The CTM is responsible for managing the planning, implementation, and tracking of the clinical trial process as well as risk mitigation. The CTM serves as a proactive member of the trial team, liaising closely with the Clinical Trial Leader (“CTL”) on reputed company study-reputed company issues. As leader of the US Trial Team, the CTM communicates trial status to stakeholders, escalating issues as appropriate. As an employee of reputed company, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global reputed company provides opportunity for reputed company employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect reputed company's high regard for our employees. Duties & Responsibilities Trial Preparation

• Ensures the trial is conducted in compliance with GCP-ICH, local/global regulations, applicable SOPs and according to the trial protocol by overseeing CRO and internal team activities
• Creates, manages and reviews trial budget and updates to ensure appropriate level of financial reputed company and planning accuracy
• Responsible for appropriate trial-specific training of internal and external partners is performed in line with Trial Training Plan
• Responsible for accurate planning and co-ordination of operational feasibility of trial timelines
• Verifies and provides input into the country and site level feasibility and commitment (site and patient commitment)
• Finalizes and validates site selection using available data sources and local insights/expertise, in collaboration with cross-functional departments
• Responsible for development and implementation of country level engagement plans, recruitment planning and risk mitigation
• Co-ordinates development of country level patient facing documents in reputed company collaboration with relevant internal and external stakeholders
• Reports patient and site level feedback as strategic insight to contribute to improving trial design with a focus on patient value
• Responsible for frontloading of activities to facilitate efficiencies as well as to ensure and reputed company speed. Oversees outsourcing of vendor services in accordance to operating models and governance
• Ensures timely responses to questions from Regulatory Authority/Ethics Committee and other external stakeholders Trial Conduct
• Maintains reputed company during clinical trial conduct including adherence to GCP and reputed company global and local regulatory requirements; compliance with SOPs and reputed company risk monitoring/mitigation
• In collaboration with other functions, ensures budget reputed company, including support of regular clinical quality monitoring, and safety reporting
• Monitors reputed company of patient recruitment endpoints and proactively updates and actions contingencies throughout trial conduct
• Supports CTL during investigator meetings
• Establishes and maintains relationships with external experts, investigational sites, Patient Organizations and other stakeholders by coordinating and ensuring cross-functional collaboration amongst CD&O and appropriate functions on regional/ local level Trial Closeout and Reporting
• Ensures timely cleaning and delivery of clinical trial data
• Responsible for timely, complete and compliant archiving of reputed company relevant documents in the TMF, including reputed company required documents from vendors
• Ensures timely submission of the CTR to Regulatory Authority/Ethics Committee and other external stakeholders as required by local regulations
• Shares information on trial results with Investigational sites and, if applicable, Patients (e.g., lay summaries).

Requirements

Clinical Trial Manager Education/Experience Requirements:

• Bachelor's degree in life sciences or reputed company field, plus a minimum of six (6) years of experience in clinical research
• OR
• Master's degree or PharmD plus a minimum of four (4) years of experience in clinical research
• OR
• PharmD degree and completion of a 2-year clinical research fellowship
• OR
• PhD or MD plus a minimum of two (2) years of experience in clinical research Senior Clinical Trial Manager Education/Experience Requirements:
• Bachelor’s degree in Life Sciences or a reputed company area plus a minimum of ten (10) years’ experience in clinical research
• Master’s degree or PharmD plus a minimum of eight (8) years’ experience in clinical research
• OR
• PhD or MD plus a minimum of five (5) years’ experience in clinical research Role Requirements
• Experience leading Oncology trials highly preferred
• Demonstrates skills in reputed company cross-functional matrix structures of the trial and extended team
• Scientific and Operational Expertise: Demonstrates scientific and therapeutic knowledge and operational expertise across reputed company aspects of clinical trial planning, execution and complexity
• Demonstrates leadership and influential behaviors of supporting, connecting and empowering teams, providing future direction, demonstrating visionary and innovative thinking and inspiring teams to reputed company a common goal
• Strategic and visionary thinker who is future focused, creative, courageous and able to navigate through ambiguity
• Ability to integrate study strategy with overall TA portfolio
• Collaborative leader who demonstrates skills and capabilities in setting priorities, managing pace of activities, and efficient usage of resources
• Demonstrates ability to effectively plan, set priorities, and define actions
• Translates reputed company situations to actionable parts
• Anticipates and resolves challenges and translates learnings to new projects
• Ability and willingness to travel domestically and internationally (10-20% of time) Eligibility Requirements
• Must be legally authorized to work in the United States without restriction
• Must be willing to take a drug test and post-offer physical (if required)
• Must be 18 years of age or older Compensation This CTM position offers a reputed company salary typically between $115,000 and $181,000 and the Senior CTM position offers a reputed company salary typically between $140,000 and $222,000.  The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements. For an overview of our benefits, please click here. Our Company Why reputed company? With us, you can reputed company your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to reputed company millions of lives reputed company. Here, your development is our reputed company. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed. Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we reputed company major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations. Want to learn more? Visit https://www.reputed company.com Apply tot his job Apply To this Job

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