Clinical research specialist Jobs in Indianapolis, IN

Job Description

Job Description

This is a remote position.

The Clinical Research Manager (CRM) is responsible for the strategic and operational oversight of clinical trials conducted across various phases. This role ensures that studies are executed in compliance with regulatory requirements, GCP / ICH guidelines, and internal SOPs. The CRM manages cross-functional teams, monitors timelines and budgets, and acts as the primary liaison between investigators, CROs, vendors, and internal stakeholders.

Key Responsibilities :

Lead the planning, execution, and management of clinical trials across multiple therapeutic areas and phases.

Oversee site selection, study start-up, patient recruitment, data collection, and close-out activities.

Ensure compliance with FDA, ICH-GCP, and other applicable regulatory standards.

Develop and maintain project timelines, budgets, and resource plans.

Supervise and mentor Clinical Research Associates (CRAs), Clinical Trial Assistants (CTAs), and study coordinators.

Review and approve study documentation including protocols, CRFs, informed consent forms, and monitoring reports.

Coordinate with cross-functional teams including regulatory affairs, data management, biostatistics, and medical writing.

Manage vendor and CRO relationships, including contract negotiations and performance monitoring.

Track and report on study metrics and provide regular updates to senior leadership.

Oversee the preparation and conduct of audits and regulatory inspections.

Minimum Qualifications :

Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field (Master’s or Ph.D. preferred).

Minimum of 5–7 years of experience in clinical research, including 2+ years in a managerial or supervisory role.

In-depth knowledge of clinical trial processes, ICH-GCP guidelines, and regulatory requirements.

Proven experience managing Phase I-IV trials across multiple therapeutic areas.

Strong project management, leadership, and team coordination skills.

Excellent written and verbal communication abilities.

Proficiency with clinical trial software (e.g., CTMS, EDC, eTMF platforms).

Ability to travel up to 20% as needed.

In addition to a dynamic and collaborative work environment, we offer a comprehensive benefits package to support our employees' well-being. Our benefits include paid holidays, Paid Time Off (PTO) policy, and medical insurance to ensure our team members have the flexibility and coverage they need. We believe in fostering a healthy work-life balance while providing the necessary support for professional and personal growth.

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E-Verify Participation :

Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at 888-897-7781 or through their website at dhs.gov / e-verify.