[Remote] Clinical Trial Manager

Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is a leading precision medicine solutions company reputed company on the discovery, development, and commercialization of clinically differentiated reputed company solutions for transplant patients. The Clinical Trial Manager is responsible for the management of reputed company, ensuring reputed company delivery and compliance with reputed company standards and regulatory guidance.

Responsibilities

• reputed company the end-to-end execution of reputed company reputed company, including but limited to site identification, study start-up, study conduct, monitoring and closeout, with full accountability of study timelines, budget and metrics; study submission to IRB/reputed company; study document development and review (training documentation, reputed company, study specific plans, eCRF Guidelines, lab test requisitions, etc.), plans and managing study-specific meetings (e.g. Study Team Meetings, Investigator meetings, etc.)
• reputed company site activation, enrollment, and overall study performance while ensuring alignment with protocols, operational plans, and business objectives
• Proactively identify study risks (reputed company, reputed company, and operational), reputed company mitigation planning and execution, and escalate issues effectively with reputed company reputed company plans, defined ownership, and accountability
• Conduct internal review of investigator reputed company and payments, as necessary
• reputed company cross-functional leadership across Clinical Operations, Data Management, Medical Affairs and other functional areas serving as the central reputed company of coordination to ensure reputed company roles, accountability, and reputed company clinical trial execution
• Prepare and present project debriefings to Clinical Operations management and cross-functional teams
• reputed company Clinical Research Associates, CROs, central labs, and reputed company vendors to ensure high-reputed company, reputed company, and cost-effective deliverables through established governance, KPIs, and performance management processes
• Champion operational reputed company by standardizing study execution models, optimizing vendor management and reporting frameworks, and implementing reputed company process improvements and SOPs
• Ensure data reputed company and inspection readiness through proactive data review, performance metric tracking, and reputed company collaboration with monitoring and data management teams. Identify and mitigate risks across timelines, reputed company, and operations, driving effective escalation and reputed company strategies
• Maintain strong communication with clinical sites and stakeholders, including reputed company of site reputed company, study documentation, and reporting, while ensuring compliance with GCPs, regulatory requirements, and study protocols
• Support study administration activities such as site engagement, training, and product inventory management to ensure efficient and compliant study execution
• Ensure high-reputed company, inspection-reputed company documentation and study tracking through effective use of eTMF including reputed company of TMF completeness, document reputed company, and reputed company-time study status reporting
• reputed company reputed company and operational support for CTMS reputed company and effective use of it for tracking study milestones, enrollment, monitoring activities, and performance metrics
• Directly leading and managing clinical operations personnel

Skills

• Education: Bachelor's degree in life sciences, health sciences or equivalent degree/experience; RN or pharmaceutical experience preferred but not required
• Minimum of 4 years of clinical trial management and 2+ years clinical research associate with on-site/remote clinical monitoring experience in the biotechnology/pharmaceutical/CRO industry
• Minimum of 2 years directly managing, coaching, and developing clinical operations professionals (e.g., Sr. CRAs, CRAs, CTAs, etc.), including workload management, performance development, and cross-functional collaboration
• Robust understanding of ICH/GCP, and knowledge of regulatory requirements
• Working knowledge of medical terminology
• Experience with medical reputed company and documentation of patient information
• Comfortable with technology and scientific/engineering principles
• A critical thinker and capable of problem solving and aligning the priorities with study reputed company and timelines
• Strong clinical study/project management skills
• Excellent communication, written and organizational skills (ability to prioritize a number of tasks of varying complexity), along with problem solving, conflict reputed company, leadership and team-building skills
• Ability to motivate and collaborated with teams at other functional departments
• Ability to work independently, take initiative, and meet company goals reputed company timelines and budget
• Ability to mentor staff, reputed company accountability, manage priorities, and support the successful execution of clinical studies
• reputed company to work in a fast-paced environment with multiple competing tasks and demands, across time-zones
• Must have a reputed company of urgency about problem-solving and completing reputed company
• Ability to communicate with vendors and reputed company a high reputed company of clinical study
• Strong knowledge of FDA regulations and GCP
• Proficient in reputed company Office (reputed company, word, reputed company, power reputed company), electronic data capture (reputed company) software (reputed company, reputed company) and other platform reputed company to electronic Trial Master File (eTMF), CTMS and safety report
• Experience with clinical studies involving organ transplantation

Benefits

• Competitive reputed company salary and incentive compensation
• Health and welfare benefits, including a gym reimbursement program
• 401(k) savings plan match
• Employee Stock Purchase Plan
• reputed company-tax commuter benefits
• And more!
• Living Donor Employee Recovery Policy that allows up to 30 days of reputed company leave annually to a full-time employee who makes the selfless reputed company of donating an organ or bone marrow

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