The Clinical Research Manager oversees clinical trials management, ensuring compliance with regulations while leading cross-functional teams and managing budgets and timelines.
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.
Be part of our network of Subject Matter Experts.
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.
Similar Jobs
Healthtech
Manages clinical research projects from start-up through completion, overseeing scope, budgets, timelines, study materials, vendors, sites, regulatory compliance, data review, reporting, and client communications. Leads multidisciplinary internal and external teams, develops protocols and clinical documents, reviews monitoring reports, supports inspections, and ensures deliverables meet contractual, protocol, SOP, and quality requirements. The role is fully remote with occasional off-site meetings and conferences.
Top Skills:
MS Office
Biotech
Oversee clinical monitoring activities and CRA team performance across clinical trials, ensuring compliance with ICH-GCP, regulations, and company SOPs. Allocate resources, review quality, support audits and inspections, manage risk resolution, approve expenses, and improve clinical operations. Lead recruitment, onboarding, performance evaluations, mentoring, task assignments, and career development. Collaborate cross-functionally, strengthen site relationships, and lead strategic task forces. Oncology experience and clinical research leadership are highly valued.
Top Skills:
Ich-GcpExcelMicrosoft OutlookMicrosoft PowerpointMicrosoft Word
8 Days Ago
Healthtech • Professional Services • Biotech • Pharmaceutical
Lead internal budgeting and sponsor negotiation for industry‑sponsored clinical trials. Develop and analyze internal budgets, translate budgets for sponsor negotiations, support CTMS/SPARCRequest processes, transition executed budgets to invoicing, and drive continuous quality improvement, tools, and training for OCR budgeting operations while ensuring compliance with institutional and regulatory requirements.
Top Skills:
CtmsDarkwingEirbEpicMS OfficeSmartstreamSparcrequest
What you need to know about the Austin Tech Scene
Austin has a diverse and thriving tech ecosystem thanks to home-grown companies like Dell and major campuses for IBM, AMD and Apple. The state’s flagship university, the University of Texas at Austin, is known for its engineering school, and the city is known for its annual South by Southwest tech and media conference. Austin’s tech scene spans many verticals, but it’s particularly known for hardware, including semiconductors, as well as AI, biotechnology and cloud computing. And its food and music scene, low taxes and favorable climate has made the city a destination for tech workers from across the country.
Key Facts About Austin Tech
- Number of Tech Workers: 180,500; 13.7% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Dell, IBM, AMD, Apple, Alphabet
- Key Industries: Artificial intelligence, hardware, cloud computing, software, healthtech
- Funding Landscape: $4.5 billion in VC funding in 2024 (Pitchbook)
- Notable Investors: Live Oak Ventures, Austin Ventures, Hinge Capital, Gigafund, KdT Ventures, Next Coast Ventures, Silverton Partners
- Research Centers and Universities: University of Texas, Southwestern University, Texas State University, Center for Complex Quantum Systems, Oden Institute for Computational Engineering and Sciences, Texas Advanced Computing Center
