Clinical Operations Manager

Alcanza Clinical Research•Woodstock, NY

11d•Onsite

About The Position

The Clinical Operations Manager leads the operational performance of clinical research staff and provides on-site oversight to ensure clinical research activities are executed and coordinated in accordance with ICH guidelines, GCP, FDA guidelines, and company policies and procedures. The role supports study performance, efficiency, patient safety, and protocol, GCP, and regulatory compliance across assigned sites and studies. The manager coordinates with internal departments and investigators to meet study milestones, budgets, and data-quality expectations. The role oversees site staffing, study assignments, performance, training, operational systems, and site processes, while identifying and escalating delivery and quality risks. It also includes people-management responsibilities, such as hiring, training, performance reviews, coaching, and employee counseling.

Requirements

Bachelor’s degree and at least 2 years of clinical research experience, or an equivalent combination of education and experience.
At least 2 years of experience as a clinical research coordinator (CRC).
Proficiency with Microsoft applications, email, electronic health records, and web applications; ability to type at least 40 words per minute.
Strong organizational, time-management, problem-solving, and project-management skills to meet deadlines.
Well-developed written and verbal communication skills.
Well-developed interpersonal and listening skills, with the ability to work independently and collaboratively with co-workers, subjects, managers, and external customers.
Ability to handle multiple tasks and adapt to changes in workload and priorities.
Professional, respectful, self-motivated, and strong work ethic.
High degree of integrity and dependability.
Ability to work under minimal supervision, identify problems, and implement solutions.
Ability to handle sensitive information confidentially and professionally in compliance with HIPAA guidelines.

Nice To Haves

At least 1 year of clinical research management experience is highly preferred.
English/Spanish bilingual proficiency is a plus.

Responsibilities

Lead and support the clinical research team, focusing on study performance, operational efficiency, patient safety, and protocol, GCP, and regulatory compliance.
Collaborate with Business Development, Patient Recruitment, Finance, Budgets and Contracts, and Quality to coordinate delivery expectations, meet study milestones and budgets, and provide quality data to sponsors.
Review performance dashboards and clinical trial systems to monitor site and patient activities, staffing coverage, and timely updates on operational activities, including required visits and calls.
Oversee resource allocations, site assignments, study team output, and performance; keep study deliverables on track and identify and escalate risks to timelines, quality, and budgets.
Assist with initial and ongoing training on protocols, CRF completion, SOPs, clinical plans and guidelines, and study timelines.
Ensure adherence to SOPs, GCP, FDA regulations, and company policies and procedures.
Oversee site staff and assess study-specific processes, training compliance, and CMP compliance; identify emerging risks and support corrective action plans at site and study levels.
Manage people-related activities, including timecards, absence tracking and approvals, new-hire training, interviewing and selection, performance appraisals, job description preparation, employee counseling, career coaching, and employment meetings.
Manage assigned site staff, proactively identify and resolve issues, and support successful site operations.
Collaborate with investigators to support patient safety and meet client goals and timelines.
Use strategic thinking and problem-solving to propose and implement risk mitigations.
Participate in and present at management or site meetings.
Perform other duties as required or assigned.