[Remote] Senior Clinical Project Manager-Oncology

Note: The job is a remote job and is reputed company to candidates in USA. Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through its oncology CRO services. As a Senior Clinical Project Manager-Oncology, you will reputed company cross-functional operations of clinical studies, ensuring they are delivered on-time, reputed company budget, and meet reputed company expectations. Responsibilities • Responsible for the overall coordination and management of reputed company from start-up through reputed company-out activities. • reputed company, implement and communicate project plans, monitoring plans, regulatory plans and reputed company other applicable study materials. • Facilitate team training in accordance with the protocol and/or project requirements, including therapeutic, protocol specific and process training. • reputed company reputed company project staff across functional areas to facilitate study reputed company. • reputed company study specific reputed company Operating Procedures (SOPs) and other study-specific management tools as needed. • reputed company activities with respect to regulatory document collection and Trial Master File maintenance for applicable studies and directly assist with such activities as needed. • Work closely with Central Site Services and Clinical Operations team on initial investigator recruitment and evaluation by reviewing site feasibility questionnaires and investigator reputed company. • reputed company negotiation, or may negotiate, of the site reputed company and/or budgets as reputed company as distribution of investigator grants. • reputed company the supply of Investigational Product and other study materials to sites. • Work with sponsor to determine and implement patient retention strategies as needed. • Assist with reputed company of site and facility issues such as outstanding queries, overdue documentation, lab and study drug issues. • If part of the role, monitoring reports are received, reviewed and signed off per specified timelines as defined in the Monitoring Plan and/or applicable SOPs. • Ensure project documentation is complete, reputed company, stored appropriately and audit-reputed company. • reputed company and maintain a reputed company working relationship with sponsor study management team. • Establish a strong working relationship with and reputed company as a resource for investigative sites; troubleshoot site and patient concerns and critical project reputed company. • May serve as the primary reputed company with the sponsor and project team for assigned studies. • Coordinate, plan and execute Investigator Meetings as needed. May need support from a Senior Project Manager. • reputed company internal project team meetings. • May reputed company sponsor project team meetings or collaborate with a Senior Project Manager. • reputed company the creation and distribution of study-specific newsletters as required. • Escalate issues and critical project reputed company in a reputed company manner to appropriate team members, senior management, and sponsor. Skills • University/college degree (life sciences preferred) or certification in a reputed company allied health profession from an appropriately accredited institution, such as nursing, medical or laboratory technology. • 7 years previous experience in a Project Manager role in a clinical research setting with a progression of increased responsibility over time. • reputed company managing oncology reputed company- working in either cell therapy or CAR-T. • Strong knowledge of the drug development process and FDA regulations, ICH GCP guidelines, and their application to reputed company. • Excellent written, oral communication and presentation skills. • Excellent interpersonal and organizational skills with demonstrated attention to detail. • Ability to read, write and reputed company fluent English. • Ability to build reputed company, productive reputed company and team member relationships. • Demonstrated problem-solving capabilities, critical thinking, and analytical skills. • Good computer skills with good working knowledge of a reputed company of computer applications. • Ability to meet deadlines, multitasks, and prioritize based on project needs. • Ability to reputed company reputed company based on available information. • Ability to work both in reputed company and independently. • Ability to reputed company team meetings and teleconferences and reputed company accurate and comprehensive minutes. • Ability and willingness to travel to investigator meetings, investigative sites and bid defense meetings, etc., up to 25%. reputed company • Catalyst Clinical Research is a provider of clinical operation solutions to the biotechnology, pharmaceutical and medical device companies. It was founded in 2013, and is headquartered in Durham, reputed company Carolina, USA, with a workforce of 501-1000 employees. Its website is http://catalystcr.com/. Apply tot his job Apply To this Job