Job Abstract

Job Description

Acting as Global SME for assigned topics and SOPs, the Global Clinical Development (GCD) Standards & Training Lead (STL) will work closely with Quality and Continuous Improvement (QCI), Global Clinical Trial Operations (GCTO), and Global Clinical Development (GCD) leaders, and internal stakeholders (e.g. Global Regulatory Affairs and Clinical Safety [GRACS], Global Clinical Supplies (GCS), Global Privacy, Finance, Procurement, Human Resources [HR]). 

The successful candidate for this position will provide key support to our company's merger and acquisition (M&A) projects.

This role will lead collaboration efforts, support and lead global projects in relation to:

QUALITY & COMPLIANCE ACROSS GLOBAL CLINICAL DEVELOPMENT:

• Lead working groups of SMEs to ensure proper analysis, improvement identification and creative solutions

• Support implementation and understanding of any new regulation with HQ/Global impact.

• Responsible for process design, management and improvement.

• Global roll out of new initiatives supporting CAPAs, compliance improvements and others.

• Ensures compliance and alignment with GCD model and regional and local regulations.

• Collaborates with GCD roles to evaluate and improve processes, KPIs and metrics.

• Acts as Global SME on specific topics and SOPs, and supports/oversees functional or cross-functional networks of process owners/subject matter experts

• Adherence to GCP, local and global policies and procedures to ensure high quality and inspection readiness. May lead implementation of enterprise-wide CAPAs.

PROCESS & PERFORMANCE METRICS:

• Lead efforts to develop new metrics or KPIs

• Oversee process and performance metrics for some processes to allow performance oversight and improvement when needed.

• Work as necessary with other global and HQ functions as well as with regional roles like ROSLs, to develop global tools and reports.

• Runs and develops reports for key stakeholders, ensures data is available and accurate in different systems and tools.                                                                 

OPERATING MODEL& PRODUCTIVITY:

• Support design and development in the GCTO operating model that align with the decided footprint, investments in infrastructure, and delivery model.

• Work to evolve GCTO structures and model to deliver a dynamic profile taking into account specific laws, environment and cost models (e.g. changing labor laws, co-employment, Functional Service Providers, out-tasking, CRO and/or niched-CRO use)

• Optimize operational delivery at all levels within GCTO, by identifying tools, systems and processes for improvement.  Suggest and spearhead efforts to address these opportunities, providing solutions and regional/global harmonization, as applicable                                  

COLLABORATION:

• Proactively looks for efficiency opportunities in GCTO operating model. Explores new outsourcing/out-tasking possibilities and needs.

• Proactively detect training needs in related topics and develop and delivers training materials and sessions for GCD roles as needed. Coordinate with GCD and our Research Division functions to ensure communication solutions (email, we, live presentation, mailboxes, surveys) and alignment with the Country, Regional and Global strategy

• Proactively lead and deliver specific projects. When needed, collaborate with other QCI roles on quality issues and regulatory inspections

• Represents GCD/GCTO/Research Division on special projects that may be pan-industry initiatives through groups such as EFPIA, TransCelerate, IMI, PhRMA

• Develop people and the organization by investing in the long-term development of others through mentoring, coaching, and continuous feedback. 

QUALIFICATIONS, SKILLS AND EXPERIENCE

EDUCATION:

• Bachelor’s degree (BA/BS) in Science or Computing Science or Engineering.

• Advanced degree (Master’s, PhD) preferred but not required.

10 years of relevant clinical trial management experience with demonstrated success required, including:

• Knowledge and understanding of end-to-end drug development and clinical trial processes, including related standards and documents, and GCD organization, roles and responsibilities. 

• Knowledge of the applicable regulations including FDA Good Clinical Practices, ICH Guidelines, and working knowledge of other major regulatory agencies Regulations and Guidance.  Knowledge of specific regulations appropriate to intended job assignments.

• Project management or leading teams experience required.

WORKING ACROSS BOUNDARIES/ INTERNATIONAL EXPERIENCE/ LEAN SIX SIGMA:

• Strong leadership skills that allow the position to work and lead effectively, across organizations and levels, in a virtual, culturally diverse environment.

• Proven track record in process improvement.

• Ability to embrace change/improvement and to influence others to this mindset

• Demonstrated ability to analyze, interpret and solve complex problems.

• Ability to think strategically and objectively.

• Business acumen

• Flexibility to accommodate US business

• Preferred:  Green or Black Belt certification in Lean/Six Sigma

ENGLISH:

• Position requires excellent oral and written skills

PROFOUND UNDERSTANDING OF DATA/METRICS, TECHNICAL SKILLS:

• Position requires experience and skills in producing and visualizing metrics as well as presentation.

#EligibleforERP

MRLGCTO

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.                              

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement?

Pay Transparency Nondiscrimination

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.

Learn more about your rights, including under California, Colorado and other US State Acts

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:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.