Manager, Clinical Operations – FSP West Region

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.

• Drive performance through metrics and key performance indicators.

• Act as the main point of escalation for performance-related issues and training requirements.

• Work in collaboration with leadership to address resourcing needs.

• Manage staff while providing coaching, mentorship, and direction on work tasks.

• Conduct performance evaluations and facilitate career discussions.

• Promote employee career development.

• Participate in interviewing, recruiting, and selecting staff members.

• Oversee and conduct induction and orientation programs.

• Keep staff CVs, training records, position profiles, and experience profiles complete and up-to-date.

• Ensure timely submission of accurate timesheets and expense reports.

• Support allocation activities and project leads/functional leads.

• Raise issues that could affect project deliverables.

• Provide training on WPDs, SOPs, local requirements, and topics related to clinical operations.

• Identify training deficiencies and ensure training needs are fulfilled.

• Ensure compliance with ethical and regulatory standards.

• Notify management of quality concerns and request or facilitate quality assurance audits.

• Review clinical systems, metrics, KPIs, and project status reports.

• Assess staff performance through remote or on-site PAVs.

• Engage in process improvement and development initiatives.

• Ensure comprehension and facilitation of risk-based monitoring.

• Contribute to bids and the procurement of new business opportunities.

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

• Lead or participate in initiatives aimed at enhancing department and company performance.

⛳️ Requirements

• A minimum of 5 years of relevant experience.

• At least 1 year in a leadership role.

• Consideration may be given to equivalent combinations of relevant education, training, and experience.

• Strong mentoring, leadership, and supervisory abilities.

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

• Familiarity with or the ability to learn company SOPs, WPDs, ICH/GCP, and FDA regulations.

• Capability to evaluate medical research data.

• Excellent organizational and negotiation skills.

• Keen attention to detail.

• Advanced written and verbal communication proficiencies.

• Good command of the English language and grammar.

• Proficient in computer usage, including data entry, storage, and retrieval.

• Willingness to travel as required.

• Skills in team building.

• Strong interpersonal and conflict resolution abilities.

• Effective problem-solving skills in a dynamic environment.

• Knowledge of medical and therapeutic areas along with medical terminology.

• Preference will be given to candidates located on the West Coast.

🏝️ Benefits

• Variable annual bonus based on company, team, and/or individual performance outcomes.

• Comprehensive national medical and dental insurance plans.

• National vision plan, including health incentive programs.

• Employee assistance and family support programs.

• Commuter benefits.

• Tuition reimbursement options.

• 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 coverage.

• Short- and long-term disability benefits.

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

• Employee Stock Purchase Plan (ESPP), allowing eligible employees to purchase company stock at a discount.

• Fully remote work arrangement available.