Senior Clinical Project Manager
Senior Clinical Project Manager
Job Type: Remote – Location: United States (Remote) – Salary: $130,000/year – Schedule: Mon – Fri
RESPONSIBILITIES:
- 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.
QUALIFICATIONS:
- 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.
PHYSICAL DEMANDS
- Prolonged periods of sitting at a desk and working on a computer.
WORK AUTHORIZATION
Prolonged periods of sitting at a desk and working on a computer.
AAP/EEO STATEMENT:
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.
OTHER DUTIES:
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.
Benefits:
- 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