Program Manager RaM
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.
(RaM = Reporting and Mapping)
The position may include any of the following responsibilities/skillset:
Subject Matter Experts (SME) of clinical database activities including programming of reports (standard, template, and study specific) and mapping procedures in support of data flow to the data repository. Provides ongoing clinical database support to other departments, when necessary, may perform development activities such as database or application development.
Broad knowledge of Clinical Development and Regulatory Affairs requirements. Conducts management and functional area meetings, contributing expertise, when necessary, through formal or informal presentations.
Oversees and coordinates clinical database activities for clinical programs including the review of eCRFs, mapping specifications, In-Life Report specifications, and program development. Ensures the adherence to standards in the development, documentation, and maintenance of libraries for reports or mapping components. Ensures adherence to clinical database standards, SOPs, and Process Guidelines. Plans appropriately to ensure adherence to timelines, performs risk assessment in the management of libraries supporting In-Life Reporting and Data Flow. Interfaces with members of study teams/project teams to integrate requirements into all deliverables. Interfaces with cross functional manager(s) to assure consistency of technical and process strategies.
Increases functional effectiveness by supporting departmental efforts to simplify and standardize procedures to the greatest extent possible. Shares best practices and leads continuous improvement efforts.
Aligns others around a positive direction and possesses a desire to solve business problems. Capable of developing challenging but achievable objectives that clearly support stated organizational goals. Interacts and communicates clinical database processes and requirements to external vendors as needed.
Leads and participates in activities including, but not limited to, improvement task forces, automations, testing of new systems and helps coordinate technical initiatives. Contributes to strategic, innovative, and creative solutions to enhance processes and increase productivity of the team.
Provides oversight to functional staff. Participates in the recruitment process, mentoring and training of new hires and ongoing technical development of functional staff. Provides input into the performance appraisals of staff to management.
Qualifications, Skills and Experience:
Highly collaborative, knowledgeable of business/operational/ workflow analytics.
Capable of creating efficient business apps and/or automate workflows. Possesses an advanced level of digital skills, including no-code bot automation, workflow analytics, and creating documentation. Demonstrates a high level of understanding with the design and development of electronic Case Report Forms (eCRFs), clinical databases and other methods of capturing and transferring data, clinical database development tools, ETL tools, reporting tools, standards, and the development process in support of clinical research.
Solid knowledge of MS Windows/Office software and exposure to web-based applications. Ability to establish and maintain good working relationships with different functional areas. Strong sense of urgency and cross functional customer focus. Ability to work independently, possesses excellent communication skills and interacts effectively with Study Teams. Strong organizational and multitasking skills, time management, and capable of coordinating multiple projects.
Minimum Education Requirements:
Bachelor’s degree in computer science or equivalent, educational exposure to software design, visual authoring tools, solution engineering capabilities, procedure language, development theory and techniques, testing methodologies, and software documentation.
Minimum Skills and Experience:
Minimum of 5 years’ experience in technology acquisition, and implementation focused on data transformations, data flow, data loading, platform operations, archiving tools and/or report writing (Examples of Apps/tools might include: Cognos, SAS, SQL, PL-SQL, Java, Contivo, InForm; PowerBI, Appian, or WhatFix)
1–2-year project management experience (either one project for a year or multiple projects totaling one year). Knowledge of Electronic Data Capture Systems or Data Management Systems
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.
Residents of Colorado
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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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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.
Residents of Colorado:
Click here to request this role’s pay range.
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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:Hybrid, Telecommuting
Valid Driving License:Yes
Number of Openings:1