Manager, Clinical Operations – FSP

This is a fully remote position, open to applicants in California, +4 more states.

📋 Description

• Supervise, train, resource, coach, and manage the performance of a team of clinical operations personnel.

• Guide staff by offering coaching, mentorship, and work direction.

• Conduct regular performance evaluations and career discussions.

• Facilitate the career development of employees.

• Interview, recruit, and select new personnel.

• Oversee and conduct induction/orientation programs for new hires.

• Maintain records of staff CVs, training documentation, position descriptions, and experience profiles.

• Ensure accurate and timely submission of timesheets and expense reports.

• Assist in allocation activities through the local resourcing process.

• Collaborate with project leads and functional leads to enhance project operations.

• Raise issues that may affect project deliverables.

• Provide training on WPDs, SOPs, local regulations, and clinical operations topics.

• Identify training deficiencies and ensure compliance with training requirements.

• Ensure compliance with ethical and regulatory standards.

• Notify management of quality issues, request QA audits, and facilitate both client and internal quality assurance audits.

• Review systems such as Activate, CTMS, Preclarus, and Clarity to assess employee and project metrics, KPIs, and project status.

• Evaluate staff performance, including conducting remote or on-site PAVs where applicable.

• Engage in process improvement and development initiatives.

• Ensure understanding and application of the risk-based monitoring approach.

• Contribute input to bids and assist in the procurement of new business as necessary.

• Collaborate with senior management and executive staff on strategic planning and business development.

• Lead or participate in initiatives that enhance departmental performance or improve processes across the company.

⛳️ Requirements

• A minimum of 5 years of relevant experience providing the knowledge, skills, and abilities required for the role.

• At least 1 year of leadership experience.

• Equivalent qualifications through a combination of appropriate education, training, and/or directly related experience may also be considered.

• Strong preference for candidates located on the West Coast.

• Advanced mentoring, leadership, and supervisory capabilities.

• Exceptional clinical trials monitoring skills, both remotely and on-site.

• Understanding of, or the ability to learn, company SOPs, WPDs, and pertinent regulations, including ICH/GCP and FDA guidelines.

• Ability to analyze medical research data.

• Strong organizational and negotiation skills.

• Keen attention to detail.

• Advanced written and verbal communication abilities.

• Proficient knowledge of the English language and grammar.

• Computer skills including data entry, archiving, and retrieval.

• Willingness to travel as required.

• Team-building abilities.

• Strong interpersonal and conflict-resolution skills.

• Problem-solving skills suited to a dynamic environment.

• Familiarity with medical/therapeutic areas and medical terminology.

🏝️ Benefits

• Variable annual bonus based on the performance results of the company, team, and/or individual.

• Options for national medical and dental plans.

• National vision plan, inclusive of health incentive programs.

• Employee assistance and family support programs.

• Commuter benefits.

• Tuition reimbursement.

• A minimum of 120 hours of paid time off (PTO).

• 10 paid holidays each year.

• Paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave).

• Accident and life insurance.

• Short- and long-term disability in accordance with company policy.

• Competitive 401(k) U.S. retirement savings plan.

• Employee Stock Purchase Plan (ESPP), allowing eligible colleagues to purchase company stock at a discounted rate.

• Opportunity for remote work arrangements.