Clinical Trials Operations Specialist

KPS Life; Ny; On-site; EUR 58,000 - 80,000; Full time

Benefits offered by this job

Travel 25%

On-site 3 days/week

Job summary

KPS Life is seeking a Clinical Study Specialist to support clinical trial teams and oversee documentation for internal and outsourced studies. The role collaborates with leadership, CROs, and vendors to ensure compliant, timely study execution.

Responsibilities include preparing reports, coordinating meetings, maintaining TMF, and supporting site activation and enrollment tracking. Travel up to 25% may be required; on-site work is expected in Warren, NJ or Armonk, NY.

Qualifications

• Bachelor’s degree or equivalent; with 2 years of relevant industry experience preferred.
• Strong attention to detail and organization; track information accurately.
• Effective communication and interpersonal skills; build relationships with partners.
• Resourcefulness and problem-solving; assess information and impacts on trials.
• Proficiency with Microsoft Office and collaboration tools (Teams, SharePoint); familiarity with CTMS/EDC/I RT/ IWR S/IVRS.
• Ability to work proactively, prioritize responsibilities, and meet deadlines.
• Basic medical terminology knowledge and familiarity with ICH-GCP guidelines.

Responsibilities

• Prepare and organize study reports, metrics, and tracking tools for oversight.
• Coordinate study meetings: scheduling, agendas, minutes, action items.
• Compile data to support feasibility assessments and site selection.
• Review study documents (informed consent, case report forms) per SOPs.
• Maintain study binders, manuals, and regulatory materials with version control.
• Coordinate materials for training sessions and investigator meetings.
• Track site activation, enrollment, monitoring visits; escalate delays.
• Maintain investigator/site information and registry postings.
• Perform TMF reconciliations under study leadership.
• Track required documentation (FDA Form 1572, disclosures).
• Maintain collaboration sites, shared drives, and repositories.
• Communicate with study sites and maintain contact information.
• Review data listings for blinded data review meetings.

Skills

Attention to detail

Communication skills

Organizational skills

Time management

Proactive work style

Problem solving

Team collaboration

Education

Bachelor’s degree

Advanced degree (optional)

Tools

CTMS

EDC

IWRS/IVRS

SharePoint

Teams

Job description

KPS Life is seeking a Clinical Study Specialist to support clinical trial teams and oversee documentation for internal and outsourced studies. The role collaborates with leadership, CROs, and vendors to ensure compliant, timely study execution.

Responsibilities include preparing reports, coordinating meetings, maintaining TMF, and supporting site activation and enrollment tracking. Travel up to 25% may be required; on-site work is expected in Warren, NJ or Armonk, NY.