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Merck Clinical Research Associate Manager, Oncology- Western Region (REMOTE) in California, California

Job Description

Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.

The Clinical Research Associate Manager manages the performance of a team of Clinical Research Associate's to support business needs.

Duties and responsibilities include, but are not limited to, the following:

  • Work allocation, staff development and performance appraisal.

  • Provides input for capacity planning, including reporting of current manpower and forecasting of Clinical Research Associate capacity and needs, to provide efficient use of resources.

  • Work with Clinical Research Associate and other functions to ensure consistency of processes and protocol implementation across the country, to reduce variability and provide predictability.

  • Interacts with sites as needed to resolve site operational issues to meet commitments in a timely manner.

  • Attend local Investigator Meetings as necessary.

  • Interface with Global Clinical Trials Operations/our company's partners on clinical trial execution.

  • Escalates site performance issues to Oncology Clinical Research Director.

People and Resource Management:

  • Manage Clinical Research Associates – career development, performance reviews, etc. Support and resolve escalation of issues from Clinical Research Associates.

  • Liaise with local Human Resources and finance functions as required.

  • Contribute to Headquarters capacity/resource planning activities to ensure efficient allocation of resources and work. Manage local conflicts between resource and work.

  • Provides training, support and mentoring to the Clinical Research Associates to ensure continuous development.

  • Ensures Clinical Research Associate compliance to corporate policies, procedures and quality standards

This is a remote/home-based role. Preferred candidate will reside within the Western territory (such as Arizona, California, Nevada, Washington) or surrounding states

Required:

  • A minimum of 2 years Clinical Research Associate management experience (preferred)

  • A minimum of 3 years of experience as a Clinical Research Associate monitoring complex therapeutic area studies.

  • Possess the ability to work independently and in a team environment.

  • Excellent people management, time management, project management, organizational, and communication skills (written and verbal) in local language and English

  • History of strong performance

  • Expertise in and excellent working knowledge of core systems and tools

  • Skills and judgment required to be a good steward/decision maker for the company.

  • Proficient in the use of core trial management systems.

  • Possess an excellent working knowledge of all applicable International Conference on Harmonisation Good Clinical Practice regulations

  • Strong organizational skills with demonstrated success required.

  • Excellent oral and written English language skills.

  • Has demonstrated the following leadership behaviors:

  • Ethics & Integrity

  • Courage & Candor

  • Drive Results

  • Build Talent

  • Collaborate

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

What we look for …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at [email protected]

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster at https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEOC GINA Supplement​ at https://www.eeoc.gov/sites/default/files/migratedfiles/employers/eeocgina_supplement.pdf

OFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

OFCCP Pay Transparency Rule at https://www.dol.gov/ofccp/pdf/pay-transp%20EnglishformattedESQA508c.pdf

We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Remote Work

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R59902

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