Merck Clinical Research Associate Manager-Central (REMOTE) in Topeka, Kansas
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.
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 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
Preferred candidate will reside within the Central territory (such as Illinois, Michigan, or Missouri) or surrounding states
Education Minimum Requirement:
- B.S. Degree
Required Experience and Skills:
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
* This is a remote-based position
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 …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
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.
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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
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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.
Flexible Work Arrangements:
1st - Day
Valid Driving License:
Number of Openings:
Requisition ID: R108543