Clinical Trials Training & Change Manager

POSITION SUMMARY:

The Clinical Trials Training Change Manager is responsible for developing, managing, and delivering
training programs for a department of 70 clinical operations staff. This individual will ensure that all team
members are proficient in clinical trial processes, systems, and compliance with regulatory standards. The
Training Change Manager will collaborate with functional leads and subject matter experts (SMEs) to
create a scalable training framework, ensuring organizational readiness and operational excellence.

PRIMARY RESPONSIBILITIES:

Design and implement training programs for SOPs, GCP compliance, clinical trial systems (e.g.,
CTMS, eTMF), and study-specific protocols.
● Collaborate with leadership to identify training and communication needs of the organization.
● Develop instructor-led sessions, workshops. and e-learning modules tailored to various roles
(CRAs, CBOMS, data managers, etc.)..
● Ensure training programs meet FDA, EMA, ICH-GCP, and other global regulatory requirements.
● Maintain training documentation to support audit and inspection readiness, monitor and report on
training completion rates and identify compliance gaps.
● Conduct refresher courses to address regulatory updates or inspection findings.
● Lead change management efforts for the adoption of new or updated processes, SOPs, or
systems within the clinical operations department.
● Monitor the adoption of new processes or systems, gather feedback, and provide follow-up
support as needed.
● Establish and maintain strong relationships with business partners, subject matter experts, and
stakeholders.
● Act as a liaison between teams and stakeholders to address resistance and foster engagement,
evaluate the effectiveness of training programs through surveys, feedback, and metrics.
● Recommend and implement improvements to training tracking and reporting processes.
● Conduct training needs assessments to identify gaps and prioritize initiatives.
● Employee must complete training related to HIPAA/PHI privacy, General Policies, Procedure
Compliance, and security as soon as possible but not later than the first 30 days of hire.
● Performs other duties as assigned

QUALIFICATIONS:

● Bachelor's degree in a relevant field (e.g., Life Sciences, Education, or Business). Advanced
degree preferred.
● Minimum of 5 years of experience in clinical operations or clinical trial training, preferably within a
CRO, sponsor, or biotech environment.
● Experience working in Clinical Systems (eTMF, CTMS, etc.).
● Experience with Salesforce Administration is preferred.
● Familiarity with Learning Management Systems (LMS) and e-learning tools.
● Strong understanding of GCP, ICH guidelines, and global regulatory requirements.
● Certification in GCP or related training preferred (e.g., ACRP, DIA certifications).

KNOWLEDGE, SKILLS, AND ABILITIES:

Familiarity with change management frameworks (e.g., ADKAR, Prosci) is a plus.
● Strong communication and stakeholder management skills to support transitions.
● Exceptional communication and presentation skills.
● Strong organizational skills and ability to manage multiple priorities independently.
● Proven ability to work collaboratively with cross-functional teams.
● Detail oriented, with solid organization, planning, and time management skills.
● Ability to manage multiple projects and priorities in a fast-paced environment.
● Strong customer focus.

PHYSICAL DEMANDS WORK ENVIRONMENT:

• This position requires the ability to use a computer keyboard, communicate over the telephone
  and read printed material.
• Duties may require working outside normal working hours (evenings and weekends) at times.