Clinical Research Project Manager

Clinical Research Project Manager

01 Jun 2022
Pennsylvania, Bluebell, 19422 Bluebell USA

Clinical Research Project Manager

Vacancy expired!

Job DescriptionCVS Clinical Trial Services™, a new CVS Health company, is part of the company’s portfolio of initiatives to advance and transform health and healthcare. As we redesign and innovate trial delivery and real-world evidence generation, we put the patient at the heart of everything we do. We are a dynamic team who have the benefit of operating in an entrepreneurial environment where bold thinking and novel approaches are not only rewarded, but they are also encouraged. Ownership and the ability to shape the way forward is empowered at all levels to accelerate progress and innovation. Here, colleagues work not only within our organization but across the CVS Health matrix, acting as one team to achieve our goals, deliver solutions and transform the future.The Clinical Research Project Manager is responsible for the management of all aspects of study services for which CVS Health is contracted with a pharmaceutical, medical device or related HC sponsor. In this role you’ll serve as the primary point of contact for the sponsor companies and is responsible for overseeing delivery of all contracted services. What you’ll do: Responsible for the overall coordination and management of clinical trials from start up through the final project deliverable Manage and lead cross-functional study teams, including third-party vendors to ensure successful completion of all components of assigned studies per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements Direct the projects technical, financial, and operational objectives. Partner with the Business Development group to develop strong relationships with current andprospective clients to generate new and/or add-on business for the future. Work to ensure that all project deliverables meet the customer’s time/quality/cost expectations. Lead study startup process, including but not limited to conduct of the study Kick-Off Meeting, developing the project operating plan, the set-up of CTS study file, and vendor Clinical Trial Agreements and budgets. Provide updates on trial progress and other relevant tracking details of study progression to the Executive Director of Project Management and other stakeholders, with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues. Ensure effective project plans are in place and operational for each trial and work proactively with the clinical trial study team to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements. In partnership 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 to ensure vendors performance to meet study needs.Required Qualifications 5+ years of clinical industry experience including demonstrated experience and competency in clinical project management tasks/processes, ICH Guidelines, GCP including regulatory requirements for the conduct of clinical development programs including clinical study design, study planning and management, monitoring, data collection, study documentation. Ability to travel for business up to 25%.COVID RequirementsCOVID-19 Vaccination RequirementCVS Health requires certain colleagues 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, religious belief, or other legally recognized reasons that prevents them from being 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 or apply for a reasonable accommodation within the first 10 days of your employment. Please note that in some states and roles, you may be required to provide proof of full vaccination or an approved reasonable accommodation before you can begin to actively work.Preferred Qualifications Experience coordinating study activities for multi-center studies Experience with Epic Knowledge of Clinical Trial technology systemsEducation Bachelor's degree or equivalent experienceBusiness OverviewBring your heart to CVS HealthEvery one of us at CVS Health shares a single, clear purpose: Bringing our heart to every moment of your health. This purpose guides our commitment to deliver enhanced human-centric health care for a rapidly changing world. Anchored in our brand — with heart at its center — our purpose sends a personal message that how we deliver our services is just as important as what we deliver.Our Heart At Work Behaviors™ support this purpose. We want everyone who works at CVS Health to feel empowered by the role they play in transforming our culture and accelerating our ability to innovate and deliver solutions to make health care more personal, convenient and affordable. We strive to promote and sustain a culture of diversity, inclusion and belonging every day. CVS Health is an affirmative action employer, and is an equal opportunity employer, as are the physician-owned businesses for which CVS Health provides management services. We do not discriminate in recruiting, hiring, promotion, or any other personnel action based on race, ethnicity, color, national origin, sex/gender, sexual orientation, gender identity or expression, religion, age, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

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