CVS Health Clinical Research Operations Senior Manager - Clinical Trial Services in Wellesley, Massachusetts
The Clinical Research Operations Senior Manager is responsible for the management of all aspects of Study Team activities for assigned project(s) from study feasibility through study close out. The Clinical Research Operations Senior Manager within CVS Clinical Trial Services will manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.What you'll do:• Manage and lead cross-functional study teams, including vendors.• Lead operational feasibility assessment and selection of sites for study conduct.• Partner with Business Development group to develop strong relationships with clients to generate new and/or add-on business. • Manage project level operational aspects of CTS Study Team including management of clinical trial timeline, budget, resources, and vendors.• Lead sponsor study startup process, including but not limited to conduct of the clinical trial Kick-off meeting, the set-up of CTS study file, site selection and finalization of site and vendor Clinical Trial Agreements and budgets. • Lead development of study plans and system set-up• Ensure effective project plans are in place and operational for each trial• Provide efficient updates on trial progress and other relevant tracking details• Implement appropriate systems, standards, and processes to ensure quality at the level of CTS sites, vendors, and data.• Lead preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team.• Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution, and quality control across the clinical team. • Ensure set-up and implementation of training; coordinate operational and therapeutic area training for internal and external study team members.• Provide oversight and direction to study team members for study deliverables• Chair Conduct working group, Sponsor Meetings, and vendor status update meetings• Effectively provide support to Study Manager(s) and Study Coordinator(s) in the conduct of the trials and continue to lead the study in all stages through study close out
• Bachelor's degree with at least 5+ years clinical trial experience OR Advanced degree (MS/PhD/PharmD) with at least 3+ years clinical trial experience:• Strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring. • Ability to travel for business up to 20%.
COVID-19 Vaccination Requirement
CVS Health requires its Colleagues in certain positions to be fully vaccinated against COVID-19 (including any booster shots if required), where allowable under the law, unless they are approved for a reasonable accommodation based on disability, medical condition, pregnancy, or religious belief that prevents them from being vaccinated.
If you are vaccinated, you are required to have received at least one COVID-19 shot prior to your first day of employment and to provide proof of your vaccination status within the first 30 days of your employment. For the two COVID-19 shot regimen, you will be required to provide proof of your second COVID-19 shot within the first 60 days of your employment. Failure to provide timely proof of your COVID-19 vaccination status will result in the termination of your employment with CVS Health.
If you are unable to be fully vaccinated due to disability, medical condition, pregnancy, or religious belief, you will be required to apply for a reasonable accommodation within the first 30 days of your employment in order to remain employed with CVS Health. As a part of this process, you will be required to provide information or documentation about the reason you cannot be vaccinated. If your request for an accommodation is not approved, then your employment may be terminated.
• Experience working at a sponsor or Contract Research Organization (CRO) company is preferred• Experience with clinical trial billing and/or budget development• Comprehensive knowledge of GCP and ICH guidelines• Experience conducting clinical research in chronic disease populations• Experience coordinating study activities for multi-center studies• Experience with Epic
Bachelor's Degree required
At CVS Health, we are joined in a common purpose: helping people on their path to better health. We are working to transform health care through innovations that make quality care more accessible, easier to use, less expensive and patient-focused. Working together and organizing around the individual, we are pioneering a new approach to total health that puts people at the heart.
We strive to promote and sustain a culture of diversity, inclusion and belonging every day. CVS Health is an equal opportunity and affirmative action employer. We do not discriminate in recruiting, hiring or promotion based on race, ethnicity, sex/gender, sexual orientation, gender identity or expression, age, disability or protected veteran status or on any other basis or characteristic prohibited by applicable federal, state, or local law. We proudly support and encourage people with military experience (active, veterans, reservists and National Guard) as well as military spouses to apply for CVS Health job opportunities.
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