Clinical Operations Manager II

October 22

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Description

• Oversee clinical operations management activities. • Define and monitor project scope, timelines and deliverables from project initiation to close-out. • Identify project-specific training for team members and notify appropriate designee to ensure completion and filing of training documentation. • Oversee trial-related activities. • Track and approve vendor payments. • Provide expert advice in the design, writing and/or review of all project-related essential documents including protocols, project management plans, case report forms, statistical analysis plans, project management plans, ICF templates, study procedure manuals, source documents, site newsletters, study reports, resource tools, essential documents, monitoring plans and report templates. • Develop and manage multidisciplinary project team members. • Organize, plan for, and produce minutes for project team meetings. • Ensure the overall quality of project services and deliverables. • Provide necessary updates and reports to the sponsor as outlined by the contract. • Plan and oversee the execution of investigator meetings as contracted. • Work with the Business Development team on budgets, proposals and change orders. • Ensure both CPC and sponsor are aware of and in agreement on any change in project scope that has a financial or resource impact. • Provide Head of Trial Master File scope of services to enable him/her to establish and maintain Trial Master Files (TMFs) and project document files, both electronic and paper. • Adhere to local, federal and international regulations, guidelines and CPC Policies, Standard Operating Procedures (SOPs) and Work Instructions (WIs). • Use appropriate discretion to proactively identify when there is a need to deviate from policies, procedures or plans and ensure deviations are appropriately documented. • Define and monitor Endpoint and Specialty Services scope, timelines and deliverables from project initiation to closeout with assistance from study assigned Clinical Operations Manager and the Head of Endpoint and Specialty Services. • Manage contracted deliverables for external committees (e.g. data safety monitoring boards, clinical endpoint committees), including but not limited to meeting scheduling, generation of meeting minutes and distribution of meeting materials. • Oversee SAE process and assure execution of safety plans. • Accurately track receipt, entry, upload and the processing of photos, acetate tracings, and other source documents submitted from sites. • Contact appropriate individuals (e.g., study site staff or study site Clinical Research Associate) regarding incomplete, inaccurate, or missing photos, acetate tracings, and other Endpoint and Specialty Services Core Lab documents as required by the project. • Oversee timely and accurate entry and cleaning of data for all study databases; maintain and file data management documentation as required. • Provide feedback to study sites on tracing and quality issues, as required by project. • Manage and conduct Endpoint and Specialty Services CPC Core Lab activities. • Provide operational support for the biostatistics and programming deliverables.

Requirements

• Nursing or BA/BS in a scientific field (or equivalent knowledge/experience) • 4 years of experience in a clinical research setting, preferably with at least 2 years of project/operations management experience in clinical research • Demonstrated ability to adequately manage all facets of a clinical trial with minimal direction • Thorough knowledge of the Good Clinical Practice guidelines and applicable FDA and ICH regulations for conducting clinical drug trials • Proficiency in Microsoft Office, particularly Outlook, Word and Excel • Excellent communication and organizational skills • Great attention to detail • Exemplary skills leading and managing multi-disciplinary teams in a clinical research setting • Ability to organize, instruct and oversee project staff, while promoting group effort and achievement • Ability to adapt quickly to new situations, manage conflicts and resolve problems effectively • Willingness to travel 20-25%

Benefits

• Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.) • Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately) • 11 paid holidays • 15 - 25 vacation days based on years of service • Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours) • In-suite exercise and relaxation room • Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics) • Flexible and remote work schedules