Standards Technical Operations Program Manager

Job Description

Job Description

The Standards Operations Program Manager is accountable for the oversight and coordination of technical standards requests in support of study start-up and maintenance activities within the Clinical Database Services (CDS) or Reporting and Mapping (RaM) functional areas. In that capacity, they oversee the day-to-day project assignments of Technical Architects ensuring adherence to clinical database standards, standard operating procedures (SOPs) and other applicable guidelines. Coordinates with functional and cross-functional resources to ensure standards request priorities are aligned and functional activities are appropriately resourced and executed on time and with quality. Attends and actively contributes to standards governance, portfolio management, and other meeting forums as necessary.

Serves as a central point of contact for the functional area related to technical standards request operations. May engage with other functional areas within GCDI to ensure awareness and alignment of process, resources, and deliverables.

Interacts with staff across our Company's multiple sites and geographies. Mentors, guides, and provides leadership. May initiate, lead, and/or participate in departmental process improvement initiatives as assigned.

Primary Activities:

• Understands the strategy for library level standards (from requirements gathering through technical implementation) ensuring technical standards requests are executed on time and with quality. Jointly with functional SMEs, participates, contributes, and leads (where appropriate) technical discussions in Standards Governance forums.
• Works independently with different functional groups to ensure appropriate resourcing and coordinates execution of standards level deliverables.
• Partners with functional area representatives to assess and promote program-level consistency in the use of database standards and program-level design.
• Provides program-related oversight and guidance to the Technical Architects and promotes quality and consistency in the use of database standards and deliverables across trials within a program.
• Keeps abreast of project management, technology and clinical data management disciplines through interaction with experts both within and outside of our Company.
• Identifies and develops improvements to data collection and data management processes and tools. Supports audits and inspections as necessary.
• May provide training and education for stakeholders. May develop, or assist in development of, reference and/or training material. May provide cross-functional internal and external communication as needed.
• Obtains internal and external stakeholder feedback on a regular basis; this may include meeting with subject matter experts or representatives from stakeholder functional areas.
• Contributes to training development for Technical Architects, including updates to the FAQs and appropriate partnering for staff as needed. Coordinates COE Meetings for the Technical Architect team to ensure appropriate knowledge sharing and problem-solving effort for consistent messaging.
• Uses excellent social, negotiating, and project management skills to perform the following tasks:
• Project plan development, execution, and change control
• Team facilitation and resource coordination
• Risk management
• Stakeholder management and communication including status reporting

Prerequisites:

• B.A. or B.S., preferably computer science, or related discipline.
• Minimum of 8-10 years in software development life-cycle with programming skills and/or project management skills.
• At least 6 years’ in Clinical Data Management (or related discipline) in technology solution implementation.
• Minimum of 6 years’ in data management, medical research, or database design and development.
• Has managed data collection/flow standards and supporting studies through the full data management life-cycle.
• At least 3 years’ working with formal project management tools and processes.

Knowledge and Skills:

• In-depth knowledge of the clinical development process; thorough knowledge of clinical data management; demonstrated knowledge of technical processes inclusive of electronic Case Report Form (eCRF) development, clinical database development, data validation tool development, user acceptance testing, data integration from different sources, data flow/migration, and application of CDASH and SDTM standards.
• Have highly effective communications skills and relationship/stakeholder management skills.
• Demonstrated leadership and project management skills.
• Strong organization, negotiation, and problem-solving skills.
• Strong customer-focus and interacts effectively with different functional groups.
• Assessing needs and translating to resourcing requirements, essential.
• Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning process, and 21 CFR Part 11.

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 ...

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

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.

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R70069