Sr Scientist, BMx Sample Mgmt and Compliance ( MERCUSR189679ENUS)
Our Biomarker Operations team is seeking a Senior Scientist in Genomics Policy to manage biomarker samples and ensure compliant utilization of clinical participant biospecimens to answer scientific questions across our company's pipeline.
In this important role, you will work collaboratively to ensure compliance of the protocol language and informed consent process, including, but not limited to clinical biomarkers, future use, and genetic sample collection and disposition. Your work will also focus on biomarker specimen management and compliance, ensuring appropriate planning and execution of specimen transfers, destructions, and study close-out activities. These activities will follow internal policies and standard operating procedures to ensure compliant specimen handling. The position will partner closely with our company biomarker operations roles, clinical teams, vendors, and several other company departments.
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.
Major activities and responsibilities:
Ensure Operation teams are executing biomarker research within Genomic Policy requirements, maintaining compliant usage of consented samples
Liaise with scientists, vendor management and project managers on efficient execution of biomarker research and continuous process improvement
Provide oversight of contractors responsible for consent and specimen management for biomarker specimens collected in clinical trials
Support Global Clinical Development processes
Utilize internal specimen inventory management systems to support activities including compliant oversight of clinical specimens for future use requests, destructions, returns for on-going care, and specimen consolidation/transfers
Support the development and implementation of job aids and other process documents
Point of contact for biomarker clinical specimen management related questions and issues from both internal and external stakeholders
Education Minimum Requirement:
BS degree with 6+ years; MS degree with 3+ years; PhD degree with 0+ years in a scientific or technological field of study
Preferred Experience and Skills:
Sample Management experience, preferably with clinical trial specimens
Clinical trial and informed consent authoring and/or review experience within a relevant biopharmaceutics industry
Familiarity with clinical trial execution including drug discovery, early and late-stage clinical development
Strong data and information system experience including Win10 tools
Desire to work in a collaborative environment, excels at communication, presentation, and organizational skills
Proven ability to simultaneously balance diverse activities for multiple projects.
Strong analytical skills with attention to detail
Strong project planning, problem solving and decision-making skills
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., Rahway, 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 …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
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.
New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.
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Number of Openings:1