CVS Health Job - 41246910 | CareerArc
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Company: CVS Health
Location: Wellesley, MA
Career Level: Mid-Senior Level
Industries: Retail, Wholesale, Apparel

Description

Job Description
The Manager of Investigational Product Management within CVS Clinical Trial Services (CTS) will manage pharmacy responsibilities to meet clinical trial requirements.

This role will:
● Manage study-specific clinical trial pharmacy operations, including coordination with central pharmacy staff. (MC)
● Review incoming project protocols and investigator brochures to identify pharmacy requirements, and risks.
● Coordinate delivery and storage of investigational product at CVS clinical trial locations.
● Ensures IP is transported and stored in accordance with FDA, GCP, IB specifications. This includes oversight of temperature logs and IP receipt and administration documentation.
● Ensure proper disposal or return of all unused IP in accordance with FDA, GCP, and IB specifications.
● Coordinate study recruiting and obtain/review of informed consent by the designated Research Pharmacist to ensure IP administration as well as risks/benefits of IP are appropriately represented to participants.
● Participates in study start-up activities and ensures pharmacy staff compliance with training and quality requirements. May participate in design and development of training for pharmacy staff.
● Identify and create IP SOPs.
● Manage and ensure Pharmacist sign-off of clinical trial pharmacy SOPS.
● Engage key stakeholders in the development and implementation of new processes, methodologies, and service enhancements.

Required Qualifications
● Bachelor's degree in applied sciences, healthcare, or related field, PharmD, Pharmacy Lrequired
● A minimum of 3 years' experience in pharmacy management, with a minimum of 3 years in clinical trials
● Experience managing or coordinating pharmacy operations for multi-center, out-patient clinical trials
● Comprehensive knowledge of GCP, ICH, IP shipping (IATA, DOT, Dangerous Goods), and other regulations for pharmaceuticals
● Pharmacy License in State of GA

COVID Requirements
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.


Preferred Qualifications
● Experience conducting clinical research in chronic disease populations
● Experience working with an IRB
● Excellent organizational and people skills
● Georgia Resident

Education
PharmD Required
Bachelor's degree in applied sciences, healthcare, or related field, PharmD, Pharmacy required

Business Overview
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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