Manager, Clinical Operations – Early Development, Oncology

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Oversee direct reports through line management, including setting goals, evaluating performance, and fostering talent development.

• Assess and predict resource requirements for the designated portfolio.

• Facilitate flexible staffing solutions, including hiring, onboarding, and offboarding processes.

• Conduct interviews, hire, train, and develop team members.

• Ensure compliance with training requirements and understanding of pertinent processes.

• Assist in resolving issues with Ethics Committees, Health Authorities, Investigational Sites, and study management teams.

• Implement organizational changes and communicate shifts in priorities effectively.

• Review and approve expenses in accordance with company policies.

• Offer coaching and mentorship, including site visits as appropriate.

• Define and implement the long-term organizational strategy for ED&CP.

• Attract, plan, execute, and monitor ED&CP clinical trials from feasibility to close-out.

• Ensure adherence to ICH-GCP, SOPs, and procedural guidelines.

• Report and escalate incidents of fraud, scientific/ethical misconduct, and breaches of health care compliance.

• Contribute to CAPA initiatives and issue resolution efforts.

• Cultivate relationships with both internal and external stakeholders.

• Develop local ED&CP capabilities and assist in study placement.

• Supervise feasibility assessments and site selection processes.

• Lead metrics reviews and follow up on action items.

• Ensure quality oversight and readiness for inspections.

• Manage the local ED&CP budget and financial reporting.

• Implement local processes and adhere to regulatory requirements.

• Create and execute systems and processes to enhance study management.

• Promote continuous improvement, innovation, and a culture based on Credo values.

⛳️ Requirements

• A Bachelor's degree or equivalent is required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).

• At least 8 years of clinical research experience within the pharmaceutical industry, CRO, or investigational site is necessary.

• Previous clinical trial experience in ED&CP is preferred.

• Demonstrated proficiency in AI literacy and a mindset geared towards the responsible use of AI tools in everyday tasks.

• Strong communication and leadership abilities.

• Experience in mentoring and coaching; line management experience is advantageous.

• Capable of leading, hiring, training, developing, and assessing personnel.

• Solid decision-making and financial management competencies.

• Effective skills in resolving issues and planning contingencies.

• Comprehensive knowledge of drug development, clinical research operations, and regulatory standards, including ICH-GCP, HCC, and relevant regulations.

• Ability to analyze and synthesize data from diverse reports and sources.

• Proficient communication skills with both internal and external stakeholders.

• Adaptable mindset with the ability to thrive in a rapidly changing environment across various therapeutic areas.

• Capable of working with minimal supervision.

• Proficient in the English language.

• Competent in computer literacy.

• Strong interpersonal and negotiation skills.

• Excellent organizational abilities and capacity to manage multiple priorities within a matrix environment.

• Able to perform tasks in a timely and accurate manner.

🏝️ Benefits

• Consolidated retirement plan (pension).

• Savings plan (401(k)).

• Vacation – 120 hours per calendar year.

• Sick time – 40 hours per calendar year; 48 hours for Colorado residents; 56 hours for Washington residents.

• Holiday pay, including Floating Holidays – 13 days per calendar year.

• Work, Personal and Family Time – up to 40 hours per calendar year.

• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child.

• Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year.

• Caregiver Leave – 80 hours in a 52-week rolling period.

• Volunteer Leave – 32 hours per calendar year.

• Military Spouse Time-Off – 80 hours per calendar year.

• Inclusive interview process and accommodation support.