Merck Hiring for Manager, Global Clinical Data Standards – Delivery Management at Richmond, Virginia Full Time

Job Description

Brief Description of Position:

Working closely with the Global Clinical Data Standards (GCDS) Director of Delivery Management for either Data Collection Standards or Data Transformation Standards, within the Global Data Management & Standards (GDMS) organization, the Manager Global Data Standards – Delivery Management is responsible for the day-to-day oversight of a team of Therapy Area Leads and/or Data Standards Specialists and their deliverables. This includes responsibility for career development, performance objectives, ongoing performance feedback and recognition, as well as annual performance appraisals for staff under their assigned area(s). The Manager will also participate in recruiting, interviewing and selection of new hires.

The Manager will support the prioritization and delivery of the book of business (BoB), strategic and functional programs/projects, and governance demands in support of one or more therapeutic areas. The manager will define the strategy for their sub-unit and, ensure team members work in a consistent manner while integrating operational excellence and best practices. The manager will champion and communicate the sub-units successful delivery or our products and services. Additionally, the manager will mentor and guide their team(s) to vet and implement new processes and technologies. The role will require a very strong knowledge of clinical information management, industry standards for clinical study data, standards implementation best practices and regulations, and technology enablement.

Primary Activities:

• Develops functional capabilities and ensures achievement of performance targets aligned with organizational goals and objectives.

• Collects and maintains data-driven delivery and operational metrics.

• Contributes to and provide insights into implementation of strategic direction.

• In support of the Sr. Director, Delivery Management, ensures project delivery alignment with established guidelines and targets.

• Drives timely, aligned delivery of quality standards and governance data management deliverables and services in support of our Company’s research pipeline.

• Manages employee performance, career development, and organizational talent and succession planning.

• Proactively engages with key customers and stakeholders on behalf of GCDS to recognize potential value-creating opportunities and to drive improvements in quality, efficiency, and productivity across the organization.

• Keeps abreast of project management, clinical data standards, and regulatory requirements for clinical data standards, technology, and clinical data management disciplines; actively engages in industry forums.

• Leads and participates in organizational initiatives as assigned.

• Supports audits and inspections as required.

Education:

• B.A. or B.S. degree in relevant discipline or equivalent experience preferably in life sciences, information technology, or related discipline.

Required Experience and Skills:

• Minimum of 10 years’ experience in Clinical Research or Clinical Data Management (or related discipline)

• Minimum of 5 years’ experience managing an organization responsible for data management delivery in a regulated environment (i.e., systems development, validation, implementation, change management)

• Minimum of 5 years’ experience in direct-line people management

• Experience managing clinical data management processes including electronic Case Report Form (eCRF) design, clinical database development and validation, user acceptance testing, external data management, data extraction, data transformation to SDTM, and analysis & reporting.

• Exceptional communication skills (oral and written), with the ability to communicate with both the technical and business functional areas.

• Strong knowledge of the Drug Discovery Process, ICH, and GCP guidelines.

• Exceptional people and thought leadership skills, with the ability to think strategically and to influence others.

• Must excel at interdisciplinary problem solving, have an innovative spirit, and demonstrated proficiency in the management of multiple projects.

Preferred Experience and Skills:

• Knowledge of and direct experience implementing industry standards (e.g., Controlled Terminologies, CDISC CDASH, SDTM, ADaM, & HL7) and requirements for submission deliverables (e.g., SDRG, ADRG, Define.xml).

• Strong leadership and proven ability to drive results in a global, matrix environment.

• Ability to effectively collaborate and problem solve across both business and technical functions.

• Experience building and/or developing an organization.

#EligibleforERP

MRLGCTO

#ONEGDMS

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 separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Under New York State, Colorado State, 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:

$164,800.00 – $259,400.00

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/) .

Search Firm Representatives Please Read Carefully

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.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid, Remote Work

Shift:

1st – Day

Valid Driving License:

No

Hazardous Material(s):

No

Requisition ID: R277193