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Senior Manager, Clinical Trials

at CVS Health

Posted: 3/1/2019
Job Reference #: 942588BR
Keywords:

Job Description

Job Title :
Senior Manager, Clinical Trials
Job ID :
942588BR
Location :
CO - Centennial
Street Address :
12600 East Arapohoe Road Suite A
Category :
Management|Project Management
Description :
Job Description
Are you an innovator self-starter? Do you want to make a difference? Are you in search of a challenge? If you feel this describes you, please read about our company and position below! CVS Health is a creative company with an exciting opportunity to work for the industry leader and largest home infusion company in the country as a Senior Manager, Clinical Trials. In this unique and challenging role, you will be responsible for leading the coordination, management, and regulatory affairs of all clinical trials programs.

We're looking for a dynamic leader that possess an aptitude for research monitoring and quality control, demonstrated leadership and problem solving skills, and excellent detail orientation and time management skills.

YOUR RESPONSIBILITIES WILL INCLUDE:
- Leads the Project Coordinator team, provides guidance/oversight, and sets tasks, priorities, and timelines for all Coram-sponsored clinical trials.

- Provides expertise in translating regulatory requirements into practical, workable plans. Oversight for all regulatory and compliance management associated with internal clinical trials, protocol development, and submissions.

- Understands regulatory process and IRB and FDA requirements, ensures compliance with regulatory agencies, and interacts with all regulatory agencies.

- Effectively works with data management and biometrics team, brings scientific rigor and sound methodology to the analysis and interpretation of clinical data, and assists generating Statistical Analysis Plans, Topline Results and Clinical Research Reports in cooperation with the clinical team.

- Responsible for all aspects of data management, analysis and reporting the results of clinical trials conducted.

- Supports and leads development of posters, journal articles, and other publications for both internal and external communications while maintaining an understanding of the current regulatory environment.

- Conducts proactive and periodic audits to ensure all clinical trial documents are filed appropriately and oversees resolution of Quality Audits and finalization of audit reports associated with all clinical trials.

- Leads and assists with training, mentoring, and development of Clinical Trial team, as the need arises.

- Coordinates and implements procedures to collect data from patient charts, medical records, interviews, questionnaires, and other sources.

- Understands, complies, and ensures compliance with Good Clinical Practice (GCP) and internal Policies and Procedures (P&Ps).

- Responsible for on-time, on-budget provision of deliverables for assigned projects.

- Defines and manages project resource needs and establishes contingency plans for key resources.

- Participates in the review and approval of documents and study support materials.

- Tracks progress of projects and identifies appropriate actions to achieve target objectives.

- Initiates improvements to enhance the efficiency and the quality of the work performed on assigned projects.

- Interacts with internal work groups to evaluate needs, resources, and timelines.

- Conducts literature searches.

- Identifies and addresses issues as required and reports any major issues to Senior Management as appropriate.

- Works effectively across departments and functional areas.

- Contributes to Policy and Procedure (P&P) development, including initial drafting as well as review as directed by supervisor.

- Responds when possible to all telephone/fax/e-mail correspondence from Investigative Sites and prospective investigators, and maintains documentation of all such correspondence or forwards contacts to appropriate personnel for response in a timely manner.

- Performs other duties and responsibilities as assigned.

Required Qualifications
- 10 years of related experience with a minimum of 5 years of clinical research and clinical trial project coordination or project management.

- 5 years of FDA, IRB Regulatory, and Compliance experience.

- Sound knowledge of medical terminology and clinical monitoring process.

- Proficiency with Microsoft business software.

Preferred Qualifications
See required qualifications

Education
* Advanced degree and clinical trial certification; or a Nursing degree and NIH clinical trial certification preferred.

Business Overview
It’s a new day in health care.

Combining CVS Health and Aetna was a transformative moment for our company and our industry, establishing CVS Health as the nation’s premier health innovation company. Through our health services, insurance plans and community pharmacists, we’re pioneering a bold new approach to total health. Coram CVS/specialty infusion services is a leading national provider of specialty home infusion and specialty pharmacy services providing infusion therapies and services to over 20,000 patients each month.

We offer a diverse work experience that empowers colleagues for career success. In addition to skill and experience, we also seek to attract and retain colleagues whose beliefs and behaviors are in alignment with our core values of collaboration, innovation, caring, integrity and accountability.

CVS Health is an equal opportunity/affirmative action employer. Gender/Ethnicity/Disability/Protected Veteran - we highly value and are committed to all forms of diversity in the workplace. 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. We comply with the laws and regulations set forth in the following EEO is the Law Poster: EEO IS THE LAW and EEO IS THE LAW SUPPLEMENT. We provide reasonable accommodations to qualified individuals with disabilities. If you require assistance to apply for this job, please contact our Advice and Counsel Reasonable Accommodations team. Please note that we only accept applications for employment via this site.

If technical issues are preventing you from applying to a position, contact Kenexa Helpdesk at 1-855-338-5609 or cvshealthsupport@us.ibm.com. For technical issues with the Virtual Job Tryout assessment, contact the Shaker Help Desk at 1-877-987-5352.

Application Instructions

Please click on the link below to apply for this position. A new window will open and direct you to apply at our corporate careers page. We look forward to hearing from you!