Clinical Operations Manager

ActivMed Practices & Research, LLC.; Woodstock (GA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

Health Savings Account

Supplemental insurances

401k with match

Job summary

Alcanza Clinical Research seeks a Manager of Clinical Operations to lead multi-site study performance and ensure adherence to ICH, GCP and FDA guidelines. The role involves coordinating with departments to meet milestones, budgets and data quality for sponsors.

The successful candidate will manage staff, training, risk mitigation, and site operations while ensuring patient safety and protocol compliance across multiple therapeutic areas.

Qualifications

• Bachelor’s degree and 2 years of clinical research experience required.
• 2+ years’ experience as a clinical research coordinator (CRC) required.
• 1+ years of management experience in clinical research is highly preferred.
• Bi-lingual (English / Spanish) proficiency is a plus.

Responsibilities

• Provide on-site operational leadership to ensure study execution per ICH, GCP and FDA guidelines.
• Collaborate with cross-functional groups (BD, patient recruitment, finance, budgets and contracts, QA) to meet milestones and budgets.
• Review dashboards and systems to monitor site activity, staff coverage and data integrity for regulatory compliance.
• Manage staffing, site assignments, training, and risk mitigation to ensure deliverables stay on track.
• Conduct trainings on protocol specifics, CRFs, SOPs and study timelines.

Skills

Leadership

Time management

Organizational skills

Problem solving

Project management

Written communication

Verbal communication

Interpersonal skills

HIPAA compliance

Multitasking

Education

Bachelor’s degree

Tools

Microsoft Office

Job description

Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in AL, AZ, FL, GA, IL, MA, MI, MO, NV, VA, SC, TN, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow.

The 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.

Essential 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.

Minimum 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.
• 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.

Alcanza Clinical Research (“Alcanza”) is a national, collaborative network of clinical research sites, founded on the mission to accelerate the development of new therapies by reducing barriers to clinical research participation for all.

We conduct research on dozens of conditions in several therapeutic areas including psychiatry, neurology, dermatology, and infectious disease. Our work is important to the patients who participate, the scientists who develop these new therapies, and the entire medical community. Because all approved medications require clinical trials, the impact of your work is exponential, reaching many thousands of future patients and improving their quality of life.

Alcanza is a culturally competent organization. We treat each other with dignity, creating an environment where all individuals feel welcome, heard, and respected for their unique perspectives and aspirations. We put considerable effort into finding exceptional employees who mirror the values most important to us: Inclusive, Impactful, Compassionate, and Determined.

Alcanza Clinical Research is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, marital status, veteran status, disability, sexual orientation, gender identity or expression, genetic information, or any other category protected by law. We recognize that diversity and inclusion is a driving force in the success of our company.