External Data Acquisition Operations Analyst II - (EDAO)
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.
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.
Create, review, and facilitate approval of external data format specification documents including, but not limited to; Data Transfer Specifications (DTS), Electronic Data Transfer (eDT), Interchange Format Agreements (IFAs) for new vendors and data types, and Protocol Specific Addendums (PSA).
Coordinate with external vendors, Information Technology (IT), and the other supporting functions to validate external data transfers into Merck’s data management system in accordance with detailed transfer specifications.
During the in-life portion of a study, and in preparation for interim and end-of-study database locks, execute and review output of assigned reports to ensure completeness of data transfers; communicate and resolve external data loading issues with vendors and IT, as appropriate.
Participate in process improvement initiatives, departmental meetings, and special projects as assigned.
Supports audits and inspections as necessary.
At least B.A. or B.S. degree, preferably in Medicine, Pharmacy, Nursing, Biological or Computer Sciences, or health care related discipline.
Knowledge and Skills:
Data management, medical research, or database design and development knowledge required.
2 years of data management, medical research, or database design and development experience preferred.
At least an understanding of the clinical development process.
Knowledge of database structures and available tools to manage, extract, and report data is preferred.
Exceptional communication skills (oral and written) with the ability to communicate with both the technical and business areas and external vendors.
Exceptional organizational and problem-solving skills.
Ability to establish and maintain good working relationships with different functional areas.
Ability to multi-task, work independently under pressure and adapt to changing environments.
Strong sense of urgency and customer focus.
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.
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For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.
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Expected salary range:$80,320.00 - $126,500.00
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Flexible Work Arrangements:Telecommuting, Work Week
Shift:1st - Day
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Number of Openings:2