Senior Clinical Project Manager

Job Type: Remote – Location: United States (Remote) – Salary: $130,000/year – Schedule: Mon – Fri

  • Provide oversight and leadership, therapeutic expertise, and guidance on study teams including in-house team members, CROs, and other vendors to ensure quality, resource, budget, and timeline goals are met.
  • Lead the identification and mitigation of risks to study implementation, enrollment, quality oversight, and study completion.
  • Ensure trials are initiated efficiently and completed on time, within budget, and in compliance with Standard Operation Procedures, FDA regulations, and ICH/GCP guidelines.
  • Keen attention to program and study statuses and proactively communicate issues or changes that may impact quality, timelines, and costs to senior management and key stakeholders.
  • Collaborate with cross-functional teams on developing the operational strategy (e.g., site selection, enrollment, data collection, monitoring) and accomplishing high-quality data deliverables, and in support of regulatory submissions.
  • Extensive experience in evaluating and managing CROs/vendors, and serve as a key escalation point for teams and vendors.
  • Develop and maintain strong relationships with internal cross-functional teams, CROs, and clinical research site personnel to ensure effective execution of clinical trials.
  • Develop, implement, and provide oversight of vendor budgets and contracts; may lead RFP and vendor selection including serving as the subject matter expert on budget negotiations.
  • Plan and implement quality checks for multiple clinical trials (e.g., establish and review key performance indicators, metrics, and progress reports, identify barriers to timely and successful trial execution).
  • Provide technical expertise for the development of clinical documents (e.g., protocols, informed consent, and safety).
  • Drive and support the development of work instructions and SOPs; contribute to Clinical Operations functional initiatives for role clarity and institution of best practices.
  • Ensure strong leadership and delivery through all levels of the team.
  • Travel nationally and internationally as required.
  • Ensuring compliance with SOPs and local regulations, ICH and GCP guidelines.
  • Bachelors in Life Sciences or Nursing; an advanced degree in a relevant scientific discipline is preferred.
  • 8 – 10 years of experience with expertise in the areas of clinical operations with 2-3 years of leadership experience including planning, implementing, and conducting early to late-stage oncology clinical trials.
  • Experience working within a small biotech company preferred.
  • Proven experience in developing high-performance clinical operations groups; setting expectations, creating accountabilities, and leading the team to successfully achieve its objectives.
  • Excellent leadership, interpersonal, communication, and presentation skills.
  • Effective stakeholder management, influence, and negotiation skills across a multi-disciplinary team.
  • Demonstrated understanding of pharmaceutical regulatory requirements and impact on the development of clinical trials.
  • Successful track record in study planning, execution, data cleaning, database locking, study report, generation, and regulatory inspections.
  • Therapeutic experience in global oncology clinical trials is highly desirable with experience in early phase drug development.
  • Results-oriented team player capable of working collaboratively with colleagues while building strong relationships.
  • Must be self-motivated, able to evaluate and resolve complex problems, and adaptable to a dynamic global teams environment.
  • Expertise in CRO & vendor management.
  • Expertise in quality and GCP requirements to ensure the organization remains compliant with ICH GCP and other global regulatory guidelines or laws.
  • Prolonged periods of sitting at a desk and working on a computer.

Prolonged periods of sitting at a desk and working on a computer.


Remegen Biosciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics.


Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Flexible spending account
  • Health insurance
  • Health savings account
  • Life insurance
  • Paid time off
  • Professional development assistance
  • Referral program
  • Vision insurance

Let employers find you