Clinical Systems Implementation Team Lead
MSD
Summary
Clinical Systems Implementation Team Lead within BEO manages the full range of activities related to the successful validation, implementation, and adoption of applications that support our company's clinical trials. The role also has people management responsibility for team members supporting similar activities.
Job description
Responsibilities
- Partner with a cross-functional team of functional SMEs and end-users to independently assess emerging business needs and work with IT to identify innovative solutions.
- Monitor technology trends to match business needs, profile partners and vendors and map capabilities to requirements.
- Create high-impact business cases for innovation opportunities and advance solutions from proof of concept to pilot and implementation at scale.
- Collaborate with user experience experts and collect feedback from users.
- Engage with business and IT sponsors to develop and drive the technology and innovation roadmap.
- Identify and manage KPIs to measure outcomes and success of technology solutions.
- Provide workstream or sub-stream leadership for larger technology initiatives.
- Create change and communication plans to support adoption of technology.
- Provide system ownership of assigned systems, including system migrations and decommissioning.
Team Management
- Manage team members that provide business system ownership of operational systems.
- Ensure proper allocation of resources to maintain effective system support.
- Identify need for and provide justification for additional headcount.
- Conduct regular 1:1s, provide constructive feedback, conduct performance reviews, and manage risks and escalations.
- Obtain sufficient understanding of supported applications to proactively identify challenges and serve as back-up.
- Discuss development opportunities and career planning with team members.
- Ensure compliance to required training for all team members.
Education
BS degree with 10 years' experience; OR MS/MBA/JD degree with 8 years' experience; or PhD degree with 5 years' experience in Science, Clinical Research, Computer Science, or similar fields.
Experience and Skills
- Two to five years of people management experience is required.
- Broad understanding of drug development - safety, clinical trials, trial design, data management, trial operations, regulatory, privacy, ICH, and GCP required.
- Ability to quickly gain thorough understanding and become subject matter expert in a new business area.
- Strong verbal & written communication skills.
- Ability to proficiently interact with all levels of management and manage senior/Executive level stakeholders.
- Project and Resource management experience.
- Deep knowledge of Clinical Trial processes and quality management and control tools.
- Experience with critical clinical systems such as CTMS, eTMF, EDC, clinical portal and basic reporting and MS Office tools.
- Understanding metrics and being able to identify trends.
- Experience in System Validation and Implementation, systems analysis and systems maintenance/support.
- Exposure to a global environment with multi-cultural and organizational operating models.
- Management and leadership skills, analytical ability, good judgment, ability to multi-task, conflict resolution expertise and discretion.
- Customer service orientation and ability to work effectively with clients, third party vendors, quality and IT management/staff.
- Experience in training user community.
Requirements
- BS degree with 10 years' experience; OR MS/MBA/JD degree with 8 years' experience; or PhD degree with 5 years' experience in Science, Clinical Research, Computer Science, or similar fields
- Two to five years of people management experience is required
- Broad understanding of drug development - safety, clinical trials, trial design, data management, trial operations, regulatory, privacy, ICH, and GCP required
- Strong verbal & written communication skills
- Ability to proficiently interact with all levels of management and manage senior/Executive level stakeholders
- Project and Resource management experience
- Deep knowledge and understanding of Clinical Trial processes as well as quality management and control tools
- Experience with critical clinical systems such as CTMS, eTMF, Electronic Data Capture (EDC) system, clinical portal and basic reporting and MS Office tools
- Understanding metrics and being able to identify trends
- Experience in System Validation and Implementation, systems analysis and systems maintenance/support
- Exposure to a global environment, with multi-cultural and organizational operating models
- Management and leadership skills, analytical ability, good judgment, ability to multi-task, conflict resolution expertise and discretion
- Customer service orientation and the ability to work effectively with clients, third party vendors, quality and IT management/staff
- Experience in training user community
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Paid Holidays
- Vacation
- Compassionate & Sick Days
- Annual Bonus
- Long-Term Incentive
Company overview
MSD, known as Merck Sharp & Dohme outside the United States and Canada, is a global research-intensive biopharmaceutical company headquartered in Rahway, New Jersey. Founded in 1891, the company has established itself as one of the world's leading pharmaceutical corporations with a rich history spanning over 130 years. MSD operates as the international division of Merck & Co., Inc., focusing on the discovery, development, manufacturing, and marketing of innovative medicines, vaccines, biologic therapies, and animal health products. The company's extensive portfolio includes groundbreaking treatments in oncology, infectious diseases, cardiology, diabetes, and vaccines, with notable products such as Keytruda (pembrolizumab) for cancer immunotherapy, Gardasil for HPV prevention, and Januvia for diabetes management. MSD maintains a strong commitment to research and development, investing significantly in scientific innovation to address unmet medical needs worldwide. With approximately 75,000 employees globally, the company operates through four main segments: pharmaceuticals, animal health, healthcare services, and strategic alliances. MSD's mission centers on using leading-edge science to save and improve lives around the world, guided by the principle that medicine is for people, not profits.