Headlands Research

Manager

• Create and maintain new Standard Operating Procedures (SOPs), Work Instructions, and other guidance at the network and site levels in compliance with ICH-GCP and federal, state, and local regulations (United States and Canada) as applicable
• Review and edit existing SOPs, work instructions, and other guidance at the network and site levels for compliance with applicable regulations (local to both the United States and Canada) and conformity to network SOPs
• Support the development and delivery of network and site-level training events, as requested, in various formats
• Conduct consistent internal study review activities to ensure compliance with ICH-GCP and applicable regulations (local to both the United States and Canada)
• Prepare and deliver an official report detailing internal study review activities performed, categorize any findings based on level of risk, and propose actions to correct any issues or noncompliance
• Work with the aligned operations team to remediate any issues or noncompliance identified at the site and implement preventive action as appropriate
• Participate in other requested quality investigations
• Assist site operations team to develop, implement, and track Corrective and Preventive Action plans (CAPAs) within the assigned region
• Routinely assess and report to operations on the risks impacting each site in the assigned region
• Conduct and report on the quality reviews of external sites as part of the Mergers & Acquisitions (M&A) due diligence process
• Participate in the integration of newly acquired sites into the network according to the integration playbook
• Share best practices to maintain a constant state of site inspection readiness
• Attend external audits and provide updates to internal leadership
• Track and assist in the required training of Headlands employees in the assigned region
• Support the development and delivery of training materials for site employees (CRIO, applicable network systems, etc.)
• Help site directors assess employee performance to quality standards, particularly in the 90-day probationary period after hire
• Participate in continuing education opportunities to stay up to date on relevant quality initiatives, regulatory guidance, and industry best practices
• Travel required up to 30%, domestically and/or internationally

Senior Quality Manager

• Directly responsible for the development and negotiation of clinical trial budgets for assigned projects and ensuring contracts are routed and executed timely
• Creates budget grids, negotiates budget and payment terms, and routes final documents for signatures
• Reviews, negotiates, and routes clinical trial budget and contract amendments for execution
• Collaborates with individual sites on their specific trial needs
• Works collaboratively, establishing and maintaining positive relationships with internal and external entities
• Utilizes internal systems of Devana and LinkSquares for internal and external communications
• Actively and effectively communicates status of budget negotiation with key internal and external stakeholders, escalating any issues that could impact project timelines or other aspects for study start-up
• Ensures timelines and goals are met
• Assist with special projects as needed

Budgets and Contracts Manager

Recruitment

• Lead and supervise 3-5 direct reports, with a team of 15-20 indirect reports ensuring optimal recruitment performance and efficiency across all sites and studies.
• Develop and implement strategic plans in collaboration with sites to meet enrollment targets for clinical trials in multiple therapeutic areas including but not limited to infectious disease, CNS and cardiometabolic studies.
• Ensure all recruitment activities comply with regulatory requirements, ethical guidelines, and company policies.
• Manage recruitment vendor relationships, ensuring quality, adherence to contracts, and efficient and cost-effective delivery of services.
• Design and optimize patient journeys, leveraging outreach to enhance trust, engagement, and enrollment rates.
• Implement a process to receive and implement participant feedback for continuous improvement.
• Work with the Patient Recruitment Manager to resolve any participant concerns and escalations.
• Identify and solve recruitment challenges and barriers to meeting recruitment objectives.
• Implement and deploy strategies for lead generation through both internal (site database) and external sources (social, email marketing/blasts, text messaging, advertising (print, radio, TV, digital)).
• Generate reports and presentations on recruitment KPIs, including trends and recommendations to identify and implement process improvements to increase call center productivity and efficiency.

Director, Patient Recruitment Operations

QA Engineer

• Oversee and direct the Quality Department, ensuring its alignment with the broader business strategy and adherence to industry standards, while establishing clear goals and promoting a culture of quality, compliance, and ongoing improvement.
• Communicate, train, and author (when applicable) Standard Operating Procedures (SOPs) including periodic review/revisions of procedures and policies to ensure compliance with regulations and guidelines in both the US and Canada.
• Develop and maintain key performance indicators (KPIs) to evaluate the effectiveness of quality assurance activities and initiatives.
• Conduct and/or oversee annual and monthly quality reviews.
• Support the corporate development team through quality review of potential acquisition candidates.
• Developing and monitoring employee training as applicable to quality, including GCP, IATA, PHI, KnowB4, etc.
• Develop, implement, and maintain an internal review monitoring system and schedule.
• Report out on quality trends and metrics to aide in effective process improvement and risk management.
• Works with Regional Director of Operations, Quality Managers and Site Directors to ensure quality incidents are investigated, root cause analysis is performed, and a CAPA has been implemented and monitored for effectiveness.
• Partners with regional leaders and site teams to identify potential changes and opportunities for process improvement.
• Provide guidance, support, training and interpretation of regulations, guidelines, and policies
• Supports coordination of sponsor audits, regulatory inspections, and mock audits.
• Oversee documentation, reporting and closure of significant compliance and/or site review findings.
• Acts as backup Quality Manager for all sites within the network.
• Serve as the Quality Leader for assigned sites, providing direct hands-on support with quality reviews, audits/inspections, and CAPA resolution to reinforce site-level compliance and readiness.
• Facilitates New Hire Orientation and on boarding in collaboration with HR for clinical operations to specific functions related to quality.
• Develops and implements a mentorship program for new site employees to foster quality across the enterprise.
• Facilitates CTMS training in collaboration with ESource team.

Director, Clinical Quality Assurance

• Work remotely under the supervision of the Patient Recruitment Manager on recruitment activities for assigned clinical trials
• Master protocol specific inclusion/exclusion criteria and participate in development of recruitment strategies and plans
• Phone screen potential study participants and assess preliminary subject eligibility
• Make 60+ outbound calls per day and answer incoming calls from interested patients
• Enter and ensure accurate collection of patient information into the clinical database while on the phone
• Schedule potential participants for on-site visits and pass qualified patients to Sr. Patient Recruitment Specialist for detailed pre-screening
• Review patient database, vendor portals and other electronic platforms to identify and initiate contact with potential study patients
• Ensure courteous and efficient service to all callers and support team and cross-functional members
• Track recruitment results and attend and contribute to department meetings

Patient Recruitment Specialist

Financial Planning and Analysis

• Headlands Research: network of advanced clinical trial sites operating 20+ sites across the US and Canada
• Fully remote, temporary (6 months) FP&A Manager reporting to the CFO
• Create, update, and maintain detailed revenue forecasts submitted monthly by sites and update discounted pipeline forecast
• Prepare the monthly financial reporting package using data pulled from NetSuite and clinical volume data
• Produce documents shared with centralized accounting teams as part of the financial close process
• Work with departments and sites to prepare and consolidate the 2026 budget
• Partner closely with accounting on the monthly close process and improve predictability of financial results
• Work cross-functionally with other departments in execution of role duties