Clinical Operations Manager

SiteBridge Research•Chapel Hill, NC

10d•Remote

About The Position

The Clinical Operations Manager is an experienced clinical research professional who provides oversight and support to Clinical Research Coordinators (CRCs) and site staff across multiple sites or satellite locations within our site network. This role requires in-depth industry understanding, knowledge, experience, and flexibility to make informed and effective decisions independently. The Operations Manager is responsible for site oversight, including study readiness, CRC and site performance, and overall site performance against key performance metrics for each assigned study. The Operations Manager maintains a staffing plan for the resourcing and utilization of site operations team members across multiple locations or larger sites to achieve performance objectives, identify opportunities or gaps, and implement plans accordingly. This role also supports study start-up, maintenance, and close-out activities, and partners cross-functionally with recruitment, budget, and finance teams to drive site success. In addition, and most importantly, this role represents the SiteBridge Research mission and vision by focusing on the trusted physician/patient partnership from start to finish for every clinical trial conducted at the site and is key in transforming clinical research for every participant. The position will maintain the operational excellence required of clinical sites/staff involved in clinical studies and ensure ICH/GCP and SOP compliance. The person in this role will report to the Executive Director of Site Operations. The position is remote with up to 30% travel at time during peak study activities for candidates with prerequisite experience.

Requirements

Bachelor's degree minimum: a combination of education and related technical/professional experience may be substituted for the degree requirements and will be considered on a case-by-case basis
Minimum of four (4) years of clinical research or related experience.
Experience as a CRC, CRA, Site Lead, Site Manager, or related is required
Minimum of 2 years of experience supervising or overseeing CRCs or site staff, including staffing and resource planning, is required
Bilingual, Spanish speaking candidates are encouraged to apply
Proven success overseeing performance across multiple sites or locations within an organization
Demonstrated knowledge of clinical trial operations and execution related to but not limited to start-up, regulatory submission, site feasibility, ect.
Excellent working knowledge of FDA & ICH GCP regulations and guidelines is required
Experience with eSource, eRegulatory, and CTMS is required
Experience in study document preparation (CRF, eSource, logs, SOPs, etc.) is a plus
Strong preference for experience within multiple phase research and therapeutic areas
Experience with necessary clinical study and staff records related to clinical study activity which includes case report forms, drug dispensation records, etc.
Excellent communication skills, attention to detail, problem-solving, follow-through, and organizational skills, with the ability to multi-task and work under/meet deadlines
Detail-oriented and meticulous in all aspects of work
Superior interpersonal, organization, and management skills
Capable of working independently with minimal supervision
Understanding of medical terminology as well as standard clinical procedures and protocols
Strong project and time management skills
High level of collaboration, customer orientation awareness and focus
Skilled with standard computer programs including the MS Office suite
Strong interpersonal, written, and verbal communication skills

Responsibilities

Provide day-to-day oversight of CRCs and site staff across multiple sites or satellite locations, ensuring study readiness, protocol compliance, and consistent execution across the portfolio
Own site and CRC performance against key performance metrics for each assigned study, identifying gaps early and implementing corrective action plans
Drive accountability for patient enrollment, ensuring sites own the enrollment plan to meet recruitment goals for their specific studies
Responsible for CRC hiring, onboarding, training, performance management, and retention across all assigned sites and satellite locations
Support project start-up, maintenance, and close-out activities across assigned sites, including study start-up and close-out, recruitment, and regulatory submissions
Identify barriers to timely study activation, efficient coordination, and site performance, and partner with appropriate teams to identify and implement solutions
Partner cross-functionally with recruitment, budget, and finance teams to drive site success and support forecasting and financial performance at the site level
As necessary, step in and fill site and study level needs including but not limited to site set-up and CRC duties to meet SiteBridge and sponsor needs
Evaluate and communicate metrics of all activity related to assigned sites and studies, and provide summary findings and recommendations to leadership
Track study activities to ensure compliance with standard operating procedures (SOPs), protocols, and all related local, state, and national regulatory and institutional policies
Prepare, participate in, and follow-up on audits/inspections as needed, including direction for audit prep and any required follow up post audit
Participates in required training and education programs
Participate in meetings (ie., Investigator Meetings, Site Trainings, Conferences) and seminars to update knowledge of clinical research and related issues as necessary
Other duties and support as assigned related to site and study operations
Travel is required (up to 30%) for projects related to site development and operations