Senior Consultant, eClinical Systems & Operational Enablement

Just In Time GCP; Warrington Township (Bucks County); Hybride; USD 130 000 - 190 000; Plein temps

Avantages offerts par ce poste

Remote & hybrid roles available

Competitive compensation

PTO & holidays

Healthcare coverage

Retirement savings with company match

Résumé du poste

Just in Time GCP is seeking a Senior Consultant for eClinical Systems & Regulatory Enablement to join our expert team in delivering high-quality support across the life sciences industry. You will align clinical technology, processes, data, and quality with GCP expectations to ensure inspection-ready systems and efficient operations.

The ideal candidate has 7+ years in eClinical environments, strong Veeva Vault experience, and a track record of leading complex engagements with independence.

Qualifications

• Bachelor’s degree in a relevant field or equivalent experience.
• 7+ years in eClinical systems, clinical operations, life sciences consulting, or related regulated industry.
• Ability to lead complex workstreams with substantial independence.
• Experience with Veeva Vault (Clinical/Quality) or similar platforms; certifications desirable.

Responsabilités

• Lead complex eClinical workstreams including implementation, configuration, validation, migration, and UAT.
• Facilitate workshops with Clinical Operations, Quality, IT, Data Management, and vendor stakeholders.
• Translate business needs into system requirements, data mapping, and migration plans.
• Drive delivery improvements and enable automation in regulated environments.

Connaissances

eClinical systems

Veeva Vault expertise

Regulated life sciences

Formation

Bachelor’s degree in a relevant field

Outils

Veeva Vault

Description du poste

Join the Just in Time GCP Team

At Just in Time GCP, we simplify clinical compliance to clear the path forward for biotech and pharma sponsors. Our work helps organizations meet GCP expectations with confidence so that compliance never slows down progress. We’re currently looking for a

Brief Description

Join the Just in Time GCP Team. At Just in Time GCP, we simplify clinical compliance to clear the path forward for biotech and pharma sponsors. Our work helps organizations meet GCP expectations with confidence so that compliance never slows down progress. We’re currently looking for a Senior Consultant, eClinical Systems & Operational Enablement to join our team of experts delivering high-quality support across the life sciences industry.

What You’ll Do

In this role, you’ll help clients align clinical technology, business processes, data, people, and regulatory and quality expectations to build strong, inspection-ready systems and ways of working.

Responsibilities Include

Client Delivery

• Independently lead complex eClinical workstreams or defined engagements involving system implementation, configuration, optimization, migration, requirements gathering, process and workflow design, validation and UAT, solution design, operational readiness, and system or process assessments.
• Lead cross-functional workshops and solutioning sessions with client Clinical Operations, Quality, IT, Data Management, and technology or vendor stakeholders.
• Translate clinical and business needs into practical system requirements, workflows, configurations, data mapping, system and data migration, reconciliation, transition requirements, and implementation recommendations.
• Exercise sound judgment to guide analysis, delivery activities, risks, dependencies, and delivery issues appropriately.

Business Growth & Market Influence

• Support scoping, proposal development, client presentations, and expansion discussions for eClinical systems and technology-enabled services by applying delivery experience and client insight.
• Identify emerging client needs related to clinical technology, system adoption, data, operational readiness, and technology-enabled service opportunities; communicate relevant opportunities to account or engagement leadership.

Domain / Capability Leadership

• Provide focused expertise in one or more eClinical technology domains, with particular emphasis on Veeva Vault (e.g. Clinical, Quality). Experience with other comparable regulated life sciences technology platforms is also valued.
• Guide clients and team members on complex issues and how technology supports clinical operations, quality, GCP compliance, data integrity, oversight, and inspection readiness.

Methods, Assets & Offerings

• Develop or materially improve eClinical methods, templates, tools, accelerators, migration approaches, and other reusable assets based on project experience.

People & Practice Development

• Coach Consultants and Associate Consultants, review work for quality, share expertise, and help develop stronger consulting and eClinical delivery capabilities.

Innovation & Continuous Improvement

• Lead focused improvements to eClinical delivery methods, tools, or internal processes, including practical uses of automation and AI in regulated environments, and help teams adopt more effective ways of working.

What You Bring

We’re looking for someone who brings a combination of expertise, initiative, and collaboration. Ideal candidates will have:

• Bachelor’s degree in a relevant field or equivalent combination of education and experience.
• Typically 7+ years of relevant eClinical systems, clinical technology, clinical operations, life sciences consulting, or related regulated-industry experience.
• Proven ability to lead complex workstreams or defined consulting engagements with substantial independence.
• Experience in one or more areas such as system implementation or configuration, optimization, data and system migration, requirements or process design, testing/UAT, validation, operational readiness, and training/change enablement.
• Experience with Veeva Vault (Clinical, Quality), or comparable regulated life sciences technology platforms is preferred. Veeva certifications or other relevant system certifications or qualifications are desirable.
• Working knowledge of GCP, 21 CFR Part 11, Annex 11, data integrity principles, and computerized system validation expectations relevant to regulated clinical technology.
• Strong understanding of clinical operations and/or clinical quality processes, with the ability to connect technology decisions to the business processes, data, roles, and GCP responsibilities they support.
• Strong client-facing consulting, workshop facilitation, stakeholder management, problem solving, recommendation development, and communication skills with both technical and non-technical audiences.
• Curiosity and learning agility to deepen expertise in one area while expanding into adjacent clinical technologies and emerging capabilities, including an interest in exploring how AI and automation can improve clinical systems, processes, and delivery.

You’ll thrive here if you value high-quality outcomes, communicate with clarity, and embrace innovation to make an impact.

Why Choose Just in Time GCP for Your Next Career Move?

At Just In Time GCP, We Take Pride In Knowing Our Work Helps Bring Safe, Effective Treatments To Patients Faster. Our Team Operates In a Dynamic, Results-driven Environment Shaped By Our Core Values

• Community. We build meaningful relationships with our employees, clients, and partners, fostering a collaborative environment where everyone feels supported, valued, and empowered.
• Pioneer. We lead with curiosity and innovation, continuously seeking better ways to solve complex challenges.
• Premier. We are committed to excellence, delivering high-quality solutions that exceed expectations.
• Steadfast. We act with integrity and reliability, standing firm in our commitment to our clients, our team, and our mission.

You’ll be part of a team that values people, purpose, and performance in equal measure.

• Flexible Work Environment. Remote and hybrid roles available.
• Competitive Compensation. Reflective of your skills and the value you bring.
• Work-Life Balance. PTO, paid holidays, and summer half-day Fridays.
• Comprehensive Healthcare. Medical, dental, vision, life insurance, and income protection.
• Retirement Savings Plan. Includes a company match.
• Collaborative Culture. Join a team that enjoys what we do and supports one another.

Location Requirement

To be eligible for consideration, candidates must reside in one of the following states: Pennsylvania, North Carolina, Kansas, Missouri, Florida, Indiana, South Carolina, Massachusetts, Texas, Georgia or New Jersey.

Ready to Make an Impact?

Applicants must be authorized to work in the United States at the time of application. We do not offer visa sponsorship and are not considering candidates with F-1/OPT work authorization.

Just in Time GCP endeavors to make the application process accessible to all users. If you need assistance completing the application process, please contact Just in Time GCP Human Resources at [e-mail]. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.

Just in Time GCP is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Just in Time GCP. Empowered People. Trusted Partners. Meaningful Impact.