Director, GCDI Operations
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
Working closely with the Head of Global Clinical Data Integration (GCDI) within the Global Data Management & Standards (GDMS) organization, the Director of GCDI Operations is responsible for coordinating efforts across global GCDI functions pertaining to resource forecasting, 3rd party contracting and invoicing, financial forecasting, operations reviews, and strategic innovation initiatives. As the Leader of the Global Innovation Forum, works with global leaders to ensure appropriate governance oversight, metrics and analytics, and process design methodology is employed to achieve targeted productivity improvements and business outcomes. Plays a key business leadership role in helping to define GCDI strategy and to achieve its operational objectives.
The Director of GCDI Operations serves as a core member of the GCDI Leadership Team, proactively engages with stakeholders inside and outside of GCDI, and across global sites to drive efforts critical to the success of GCDI and GDMS more broadly.
1.Develops and implements GCDI Operations processes and capabilities, and ensures achievement of performance targets aligned with organizational goals and objectives.
2.Coordinates management of GCDI efforts related resource forecasting, financial forecasting, contracting, and invoicing ensuring alignment with established guidelines and targets.
3.Facilitates preparation and conduct of GCDI Operations reviews to ensure achievement of organizational goals and objectives.
4.Leads the GCDI Global Innovation Forum, ensuring appropriate governance, metrics and analytics, and process design methodology is employed to achieve targeted productivity improvements and business outcomes.
5.Proactively engages with key customers and stakeholders on behalf of GCDI to recognize potential value-creating opportunities and to drive improvements in quality, efficiency, and productivity across the organization.
6.May be responsible for manage direct reports inclusive of setting organizational objectives; conducting performance management activities; and providing mentoring, coaching, and career development guidance.
7.Keeps abreast of clinical data management and associated information technology disciplines and industry trends
8.Leads and participates in organizational initiatives, as assigned.
9.Supports audits and inspections, as required.
10.As a member of the GCDI Leadership Team, provides strategic and operational input into decisions impacting the direction and success of GCDI and GDMS
Education Minimum Requirement:
B.A. or B.S. degree, preferably in life sciences, business operations, or related discipline.
Required Experience and Skills:
1.Minimum of 10 years’ experience in Clinical Data Management
2.Minimum of 5 years’ experience managing cross-functional operations in a regulated environment under GCP and ICH guidelines (ie., systems development, validation, implementation, and change management)
3.At least 5 years’ experience directing resources with a minimum of 3 year’s direct-line management experience
4.At least 5 years’ experience developing and implementing processes using formal process methodology
5.Minimum of 5 years experience working with technology vendors and/or service providers
Preferred Experience and Skills:
1.Experience with contract management, finance, and resource forecasting
2.Experience using Six Sigma methodology and analytics to improve business performance
3.Strong leadership and ability to work effectively in a global, matrix environment
4.Ability to effectively collaborate and problem solve across both business and technical organizations and functions
5.Strong communication skills, both written and verbal
6.Ability to think strategically, innovate, and apply technology to drive business outcomes
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job: Clinical Data Management
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck