Senior EDC Lead

About the role

The Senior EDC Lead is a key member of the Clinical Data Strategy Organization within AbbVie Data Science. This role is responsible for the development and delivery of clinical trial systems, ensuring compliance with regulatory standards and fostering innovation.

Responsibilities

• Develops and maintains methodologies for designing and developing clinical trial systems, aligning with industry standards and regulatory requirements.
• Ensures consistency in system design across different studies and programs.
• Manages project timelines and quality, anticipating and addressing potential issues that could impact deadlines.
• Collaborates with cross-functional teams to ensure alignment with overall program objectives.
• Maintains adherence to federal regulations, GCPs, ICH Guidelines, and AbbVie SOPs.
• Coaches and mentors team members, contributing to their professional growth.
• Led innovation and process improvement initiatives within the organization.

Requirements

• Bachelor's degree in business, management information systems, computer science, life sciences or equivalent, with a Master's degree preferred.
• At least 5 years of hands-on experience in technical study build using EDC platforms, with Medidata RAVE experience required. Veeva EDC experience is a plus.
• In-depth understanding of clinical trial processes and CDASH, SDTM.
• Proven ability to contribute to organizational initiatives and advance the company's goals.
• Strong influencing and mentoring skills in a matrixed environment.
• Effective communication and analytical skills.

Qualifications

• Experience with federal regulations and local regulations relevant to clinical development.
• Knowledge of Good Clinical Practices (GCPs) and ICH Guidelines.
• Understanding of AbbVie's Standard Operating Procedures (SOPs).
• Ability to stay updated on new and evolving regulations, guidelines, and policies.

Benefits

• Paid time off (vacation, holidays, sick leave)
• Medical/dental/vision insurance
• 401(k) retirement plan
• Short-term incentive programs

Schedule

This role is primarily site- or office-based but can occasionally be performed remotely. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely, following the policies and regulations in place at their location.

Pay

$84,500 - $162,000 USD