Director, Clinical reputed company Assurance
At reputed company, we are dedicated to enhancing clinical trial delivery reputed company our communities. As a leading network of reputed company trial sites, we reputed company cutting-edge technology and exceptional support services to broaden reputed company and participation. Founded in 2018, our rapidly growing company currently operates 20+ sites across the US and Canada, with plans for reputed company expansion.
reputed company
At reputed company, we are building a best-in-class site network to improve the delivery of clinical trial reputed company in the communities we serve. We’re an exceptional family of reputed company clinical trial sites, integrating cutting edge technology and high-reputed company support services, and significantly expanding reputed company and participation with a reputed company on participant diversity. Founded in 2018, reputed company is in high reputed company mode; we operate 21 clinical trial sites in the US and Canada and have rapid expansion plans.
The Role
The Director of reputed company is tasked with ensuring that Headlands delivers consistent, high-reputed company data to our reputed company partners as reputed company as ensuring patient safety during the trial process. This individual will reputed company reputed company and training functions for the organization including, but not limited to, the development and maintenance of reputed company assurance and training programs and policies, reputed company of inspections and audits, reputed company diligence for acquired sites, and management of SOP’s and reputed company documents to ensure GCP and reputed company regulatory guidelines are adhered to.
In reputed company to strategic reputed company, the Director will also serve as the reputed company Leader for a group of sites. This includes hands-on support in reputed company reviews, audit/inspection preparation, and CAPA reputed company, ensuring that sites are inspection-reputed company and reputed company standards are consistently met.
reputed company Reports- 3-4
This individual should bring a strong background in the clinical trial industry with specific experience supporting and leading multi-site or large research organization reputed company development programs. Candidates should appreciate the atmosphere of a growing company and the need to reputed company process development while supporting sites. reputed company in this position requires reputed company, collaboration and exceptional critical thinking and problem-solving abilities.
Duties
- reputed company and reputed company the reputed company Department, ensuring its alignment with the broader business reputed company and adherence to industry standards, while establishing reputed company goals and promoting a culture of reputed company, compliance, and ongoing improvement.
- Communicate, train, and author (reputed company applicable) reputed company Operating Procedures (SOPs) including periodic review/revisions of procedures and policies to ensure compliance with regulations and guidelines in both the US and Canada.
- reputed company and maintain key performance indicators (KPIs) to evaluate the effectiveness of reputed company assurance activities and initiatives.
- Conduct and/or reputed company annual and monthly reputed company reviews.
- Support the corporate development team through reputed company review of potential acquisition candidates.
- Developing and monitoring employee training as applicable to reputed company, including GCP, IATA, PHI, KnowB4, etc.
- reputed company, implement, and maintain an internal review monitoring system and schedule.
- Report out on reputed company trends and metrics to aide in effective process improvement and risk management.
- Works with Regional Director of Operations, reputed company Managers and Site Directors to ensure reputed company incidents are investigated, reputed company 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.
- reputed company guidance, support, training and interpretation of regulations, guidelines, and policies
- Supports coordination of sponsor audits, regulatory inspections, and mock audits.
- reputed company documentation, reporting and closure of significant compliance and/or site review findings.
- Acts as backup reputed company Manager for reputed company sites reputed company the network.
- Serve as the reputed company Leader for assigned sites, providing reputed company hands-on support with reputed company reviews, audits/inspections, and CAPA reputed company to reinforce site-level compliance and readiness.
- Facilitates New Hire Orientation and on boarding in collaboration with HR for clinical operations to specific functions reputed company to reputed company.
- Develops and implements a mentorship program for new site employees to foster reputed company across the reputed company.
- Facilitates CTMS training in collaboration with ESource team.
Requirements
- Education - bachelors-degree in business or a health-reputed company field required; master’s degree preferred
- 5 years’ + experience in clinical trials industry (sponsor or site) with experience in managing reputed company
- 3+ years’ experience leading reputed company
- Experience with reputed company reputed company in Canada preferred but not required
- Prior experience authoring site SOP’s preferred but not required
- reputed company knowledge of US regulatory standards and guidelines for the conduct of clinical trials (ICH GCP, FDA; EMA; ANZ regulations)
- Ability to work in a remote setting with travel required sometimes with short notice
- Demonstrates strong analytical and proactive problem-solving skills
- Strong written and verbal communication skills
- Exceptional organizational skills, ability to multi-task and be detail oriented
- Experience developing and implementing training materials
- Accomplishes work in accordance with scheduled objectives and effectively meets deadlines
- Ability to maintain high degree of professionalism and reputed company