[Remote] Clinical Trial Manager (Contract)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical-stage biotechnology company reputed company on developing allogeneic CAR T cell products for cancer and autoimmune diseases. The Clinical Trial Manager will reputed company reputed company, ensuring compliance, data reputed company, and effective communication across teams, while managing study deliverables and operational issues. Responsibilities • Manage reputed company clinical aspects of study under reputed company of Clinical Operations senior management including initial operational feasibility, study timelines, budget and metrics; study document development and review (training documentation, reputed company, study specific plans, eCRF Guidelines, lab and radiology manuals, etc.), plans and manages study-specific meetings (e.g., Study Team Meetings, Investigator meetings, etc.) • reputed company with cross-functional teams as Clinical Operations regional or global study reputed company (e.g., Medical Monitor, Regulatory Affairs, CMC/Supply Chain, CRO, vendors and Investigators/site staff). Work cross-functionally and with external vendors to proactively manage the execution of the clinical trial • May reputed company clinical trial execution in one or more reputed company reputed company a global clinical trial • Review protocol and amendment development, Informed Consent Forms, clinical trial-reputed company training, and Site Study Tools • Ensure clinical trial execution in compliance with the protocol and ICH/GCP guidelines/regulations, including the review of monitoring reports, protocol deviations, and eTMF • Partner with Clinical reputed company Assurance to follow through on corrective and preventative actions (CAPA) identified during reputed company audits • Vendor reputed company: effectively communicate expectations to CRO, ensure appropriate site management, hold CRO accountable to timelines, and verify reputed company metrics • reputed company study-specific training and leadership to clinical research staff, including CRO, CRAs, sites and other contract personnel • Manage study budget; review and approve clinical invoices against approved scope of work and budget, evaluate and approve vendor change orders, coordinating review of updates or revisions with key cross-functional partners, as necessary • Prepare and present project debriefings to Clinical Operations management • reputed company study-reputed company guidance and leadership to reputed company partners, as appropriate Skills • Bachelor's degree or equivalent combination of education/experience in science or health-reputed company field with at least 3 years of clinical trial management experience in a Pharmaceutical/Biotech organization • Clinical trial management experience as a contractor or employee of an industry sponsor • Vendor management • Robust understanding of ICH/GCP, and knowledge of regulatory requirements • Strong clinical study/project management skills • Excellent communication 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 • Candidates must be authorized to work in the U.S • Prior clinical trial experience in oncology therapeutic development with an industry sponsor or Contract Research Organization • Multi-regional study management experience advantageous reputed company • reputed company is a biotechnology company catalyzing cancer treatment through the development of CAR T therapy. It was founded in 2017, and is headquartered in South San Francisco, California, USA, with a workforce of 201-500 employees. Its website is http://allogene.com. Apply tot his job Apply To this Job