Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
The position manages all aspects of clinical trial operations in the US for the Early Stage Portfolio (non-Oncology).
Adherence to Good Clinical Practices (GCP), local and global policies and procedures to conduct high-quality, inspection ready studies is essential. The position is responsible for trial quality and audit responses and completion of Corrective Action and Preventive Actions (CAPAs). The incumbent ensures a single point of contact for managing clinical trial execution in all its aspects across phase one within the US. The position has multiple touchpoints with Global Clinical Trial Operations (GCTO) and our company’s research laboratory staff in the US headquarters. Additionally, there are important interactions with Quality Assurance, Finance, Regulatory, Clinical Supplies and legal in a highly matrix-based organization.
- Provide Leadership to the country(ies): Build the best team and chart the course. This includes continual optimization of the organizational design and resources, ownership and optimization of key processes, talent and succession management, overall operating budget management and oversight of all high priority programs and studies. Adhere to our company’s standards and Research laboratory/Global Clinical Director (GCD) and GCTO goals, initiatives and expectations. Participate and support the goals and objectives of the GCTO Leadership Team. Speak with “one voice” on agreed strategies.
- Manage Clinical Operations activities and personnel within the country. Ensure that compliance, quality and timeline objectives are met for all trials executed in the country. – Work collaboratively in a matrix organization with all groups within GCTO, especially with Clinical Sciences and Study Management (CSSM), TPHARM, and Clinical Quality Managers (CQMs), to deliver objectives.
- Collaborate with Functional Service Provider (FSP) Senior, Regional and local Leadership to ensure adequate and appropriate resourcing for the company internal clinical trial portfolio
- Collaborate with Clinical Research Organization (CRO) Senior, Regional and local Leadership to ensure the successful implementation of fully-outsourced clinical trials
- Work with the Global Operations group within GCTO and Global Medical Affairs as appropriate, in site management and selection decisions.
- Support the development and management of Investigator relationships in conjunction with the research laboratory Therapy Areas, and when appropriate, Human Health colleagues.
- Contribute to the program life-cycle management through effective study allocation and execution (prioritizing programs, working with KOLs, etc.). – Take responsibility for any clinical audits, working closely with the Quality Assurance (QA) group and the Good Clinical Practice Quality and Compliance Council (GCP QCC).
- Represent GCTO and the country on strategic initiatives at all levels of the organization. Effectively manage resources to ensure appropriately skilled and high performing staff members are assigned to support the effective execution of the portfolio and achieve GCTO, GCD, and research laboratory objectives. Sets clear performance standards and holds self and organization accountable for achieving results. Embraces GCTO metrics and performance standards (KPIs).
- Represent GCTO organization both internally and externally within the industry
- Significant Management experience in a Clinical Trials setting with the ability to service and collaborate with different stakeholders within GCTO and research laboratory in a matrix organization.
- Management expertise should cover management of budget, travel, resources, headcount, processes (and controls), productivity, quality and project delivery
- A complete understanding of the International Conference on Harmonisation Good Clinical Practice (ICH GCP) and Global/Regional/Local regulatory requirements is required.
- Strong Communication skills requiring proficiency in written and spoken English and local language. The incumbent must be competent and effective in written and verbal communication.
- Strategic thinking
- 10 – 15 years of experience in Clinical Trial Operations
- BS in life science combined with proven track record of contribution to and delivery of clinical trials.
**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” that great medicines can make a significant impact to our world. 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.
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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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
Number of Openings: 1