Program Manager - Clinical Data Standards

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.
The Program Manager oversees the projects and or activities within Global Clinical Data Standards purview and the associated clinical information governance network in collaboration with the Director of Operations, Global Clinical Data Standards. They monitor, track, and control outcomes to resolve issues, conflicts, dependencies, and critical path deliverables using a consistent project management methodology. Through teamwork and a data driven approach, they would work analytically and creatively to solve problems. Coordinates our Company's standards governance network and facilitates our Company participating in and connecting with external standards related activities (e.g., CDISC, PhUSE, TransCelerate). Manages the definition, implementation, and maintenance of GCDS Standard Operating Procedures and supporting documentation to ensure compliance with worldwide regulatory and relevant internal our Company requirements.
Primary activities include, but are not limited to:
- Ensure individual projects are completed on time, within budget, and in alignment with company goals.
- Projects will have set timeframes.
- Prepare and manage project materials.
- Including a project plan, RACI, meeting materials (e.g., notes, decision log, action items, etc.), timeline, kick-offs, retrospective reviews.
- Establish appropriate metrics to track and monitor progress and quality (as necessary).
- Bring together team members.
- Communication with and motivation of stakeholders.
- Addressing pain points, risks, and maintaining quality control.
- Prepare and maintain project status reports.
- Ability to organize and run meetings efficiently.
- Ability to show critical thinking and a "think-on-your-feet" mindset.
- Lead/participate in cross-functional data governance reviews and projects.
- Lead/participate in departmental and/or cross-functional working groups and process improvement initiatives.
- Represents function in cross-functional project teams; establishes collaborations/interactions with colleagues outside the department and makes frequent contacts external to the area and/or company.
- Maintain knowledge of new technologies, clinical information industry standards, regulatory requirements, and our Company guidelines and SOPs.
- Define and oversee implementation of a standards communication plan.
- Able to work independently or as a team member or leader with equal effectiveness. Interacts with staff across multiple Compa sites. Mentors, guides, and provides project leadership for junior staff as assigned.
Experience
- Broad knowledge of and experience with clinical development & data management processes and regulatory requirements
- Extensive program and/or project management experience managing and governing clinical information standards activities.
- Awareness of industry standards (e.g., Controlled Terminologies, CDISC CDASH, SDTM, ADaM, and HL7) and submission deliverables (SDRG, ADRG, Define.xml).
- Must have awareness of project management methodologies (e.g., Scrum, Agile, Waterfall) and tool.
- Experience in defining, implementing, and managing process improvement projects and documentation.
- A broad comprehensive knowledge of the clinical trial process including data management (data collection, processing, storage, and retrieval), requirements gathering, and worldwide regulatory data management and reporting requirements.
- Exceptional verbal and written communication skills in a global environment, with the ability to communicate with both the technical and business stakeholders
- Exceptional people and thought leadership skills, with the ability to think strategically, influence others and work collaboratively with cross-functional stakeholders.
Education Minimum Requirements
- Associates Degree with minimum of 7 years work experience which includes 5 years of program management experience.
- BA/BS Preferred.
Required Expertise and Skills:
- Must have an innovative spirit, outstanding interpersonal skills, leadership and demonstrated proficiency in the management of multiple projects.
- Strong knowledge of the Drug Discovery Process, ICH and GCP guidelines
- Proven ability to work collaboratively on interdisciplinary teams. Strong interpersonal skills that demonstrate initiative and motivation. Proven ability to solve complex problems.
- Strong skills in project management
- Ability to effectively organize and manage multiple assignments with challenging timelines.
- Ability to mentor cross functional colleagues in data standards and metadata management practices.
Knowledge and Skills Desirable but not Essential:
- Direct experience implementing industry standards.
- In-depth knowledge in industry data standards, regulatory data submission requirements, and demonstrated experience in the development and implementation of standard methodology.
- Knowledge of clinical data management systems (e.g., Inform, Rave).
- Knowledge of SAS and statistical methodologies.
- Ability to leverage technical solutions to manage deliverables and associated quality with assigned projects.
- Ability to use programming and other applications to generate insights from data.
#ONEGDMS
#EligibleforERP
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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Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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Under New York City, Washington State and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected salary range:
$117,600.00 - $200,100.00
Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here (https://www.benefitsatmerck.com/) .
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Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid, Remote Work
Shift:
Valid Driving License:
No
Hazardous Material(s):
Requisition ID: R219056