Clinical Operations ManagerDepartment: Operations
Employment Type: Full Time
Location: Olympus - Sugar Land, TX
Reporting To: Mary Rogers
DescriptionThe
Manager, Clinical Operations is responsible for leading the operational performance of the clinical research staff. Provides on-site oversight to help ensure execution and coordination of clinical research activities according to ICH guidelines, GCP, FDA guidelines and follows company policies and procedures.
Key ResponsibilitiesEssential Job Duties:- Overall team management and leadership support with a focus on driving study performance, enhancing efficiencies, patient safety and protocol/GCP/regulatory compliance.
- Collaborating with other departments (Business Development, Patient Recruitment, Finance, Budgets and Contracts, and Quality) to coordinate delivery expectations, meet expected study milestones (such as site activation targets, enrollment targets, etc.), meet budgets, and delivery quality data to sponsors.
- Reviewing the performance dashboards and other clinical trial systems to oversee site and patient activities, ensure proper staff coverage, and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency).
- Overseeing resourcing allocations, site assignments and study team members' output and performance, to ensure study deliverables are on track, identifying risks to delivery or quality, and escalating any risks to clinical trial management deliverables (timeline, quality and budget).
- Assisting with initial and ongoing trainings regarding protocol specificities, Case Report Form (CRF) completion, Standard Operating Procedures (SOPs), clinical plans and guidelines, and timelines for the study.
- Ensuring adherence to standard operating procedures, good clinical practice (GCP), FDA regulations, and company policies and procedures.
- Overseeing site staff assigned to the study and routinely assessing study-specific process and training compliance, CMP compliance, and identifies emerging risks. May develop and support execution of corrective action plans at site and study level.
- Overseeing people management activities including timecards, absence tracking/approvals, new hire training, interviewing and selection, performance appraisals, job description preparation, employee counseling, career coaching and employment meetings.
- Managing assigned site staff, proactively identify and resolve issues, and work to ensure successful site operations.
- Collaborating with investigators to ensure patient safety and meeting client goals and timelines.
- Employing strategic thinking and problem-solving skills to propose and implement risk mitigations.
- Participating and presenting in management or site meetings.
- Perform all other duties as required or assigned.
Skills, Knowledge and ExpertiseMinimum Qualifications:Bachelor's degree and a minimum of 2 years of clinical research experience, or an equivalent combination of education and experience, is required. 2+ years' experience as a clinical research coordinator (CRC) is required. 1+ years of management experience in clinical research is highly preferred. Bi-lingual (English / Spanish) proficiency is a plus.
Required Skills:- Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm).
- Must possess strong organizational, time management, problem solving, and project management skills to meet project deadlines.
- Well-developed written and verbal communication skills.
- Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers.
- Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities.
- Must be professional, respectful of others, self-motivated, and have a strong work ethic.
- Must possess a high degree of integrity and dependability.
- Ability to work under minimal supervision, identify problems and implement solutions.
- Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.
Benefits- Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire.
- Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.
