Associate Manager, Clinical Operations - FSP

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

📋 Description

• Supervise, train, allocate resources, coach, and performance-manage a team of clinical operations personnel.

• Drive performance metrics and key performance indicators.

• Serve as the escalation point for performance-related issues and training requirements.

• Collaborate with leadership to address resourcing needs.

• Oversee staff management and provide coaching, mentorship, and work direction.

• Conduct performance evaluations and facilitate career discussions.

• Support employee career development initiatives.

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

• Organize and implement induction/orientation programs for new hires.

• Maintain up-to-date staff CVs, training records, position descriptions, and experience profiles.

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

• Assist in allocation tasks and project/functional leads to enhance project operations.

• Address issues that could impact project deliverables.

• Provide training on WPDs, SOPs, local guidelines, and other clinical operations subjects.

• Identify training deficiencies and ensure all training needs are fulfilled.

• Ensure compliance with ethical and regulatory standards.

• Notify management of quality concerns and initiate or facilitate QA audits.

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

• Assess staff performance through PAVs, both remotely and on-site, while monitoring skills and project execution.

• Engage in process improvement and development initiatives.

• Ensure comprehension and facilitation of risk-based monitoring practices.

• Contribute to bids and procurement of new business as necessary.

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

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

⛳️ Requirements

• Bachelor’s degree or equivalent with relevant formal academic or vocational qualifications.

• Prior experience providing the necessary knowledge, skills, and abilities to perform the role (comparable to 0 to 5 years).

• At least 1 year of leadership experience.

• Equivalency may include appropriate education, training, and/or directly related experience.

• Advanced mentoring, leadership, and supervisory capabilities.

• Excellent clinical trials monitoring competencies, both remote and on-site.

• Ability to learn and implement company SOPs, WPDs, and relevant regulations, including ICH/GCP and FDA guidelines.

• Capability to evaluate medical research data effectively.

• Strong organizational and negotiation abilities.

• Exceptional attention to detail.

• Advanced written and verbal communication skills.

• Proficient knowledge of the English language and grammar.

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

• Willingness to travel as necessary.

• Skills in team building.

• Interpersonal and conflict resolution abilities.

• Advanced problem-solving skills in a dynamic environment.

• Comprehensive knowledge of medical/therapeutic areas and medical terminology.

🏝️ Benefits

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

• National medical and dental insurance plans.

• National vision coverage.

• Health incentive programs.

• Employee assistance and family support services.

• Commuter benefits.

• Tuition reimbursement opportunities.

• 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.

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

• Employee Stock Purchase Plan (ESPP) with a discount on company stock.