Job Description
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.
Role functions as the process and country subject matter expert guiding the standard of conduct for; Site Budgets & Contracts - OR - Site Regulatory Submissions.
Supports Head of Clinical Operations Managers (COMs) and vendor partners in providing oversight for COMs within the country.
Point of escalation for budget, contact, or Institutional Review Board (IRB) related site issues
Coordinates and liaises with Clinical Research Manager (CRM), Clinical Trial Coordinator (CTC), Clinical Research Associate (CRA) (Finance and legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, Clinical Trial Research Agreements (CTRAs), and local milestones.
Oversees COMs as appropriate by partnering with vendor partners to assure operational oversight for the COMs deliverables and project assignments.
Accountable for managing country deliverable as it relates to regulatory or financial aspects of the clinical trial
Accountable for the development of the local Standard Operating Procedures (SOPs), checklists, and job aids.
Works closely with the Clinical Research Managers within the country for site initiation strategy.
Strong knowledge of regulatory and/or budget and contract regulations (FDA/ICH/GCP).
Works closely with Clinical Research Director (CRD) and local GCTO country operations to assess, prioritize, and drive execution of clinical trials in order to support and manage the pipeline and local business needs to agreed-upon timelines and budgets.
Manages the escalation of budget, contract and IRB issues within the country.
Education and experience
BS degree, life science or equivalent Health care related experience
8 - 10 years of clinical research experience
Skills
Position requires extensive experience in clinical research operations and experience with project management and coordination. Expertise of core clinical, regulatory, and financial systems.
Strong communication and negotiation skills.
Leadership skills and ability to work in a matrix environment.
Expertise in Site Budgeting/Contracting and/or Site Regulatory Submission process standards.
Familiar with ICH/GCP principals.
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.
this is a remote opportunity
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.
GCTOCRA
Residents of Colorado
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Secondary Language(s) Job Description
will send
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL [survey.sogosurvey.com]) if you need an accommodation during the application or hiring process.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)
EEOC GINA Supplement?
OFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf)
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.
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:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1
Requisition ID: R105892