About Pharm-Olam, LLC:
Pharm-Olam, LLC is a mid-size Contract Research Organization (CRO) with a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today’s emerging marketplace. Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further. We offer a unique working environment with a global team culture, competitive salary and benefits package.
Oversees and manages clinical operations activities in US and Canada to ensure quality and timely performance of all investigational site activities (activation, management and visits) and study file management for clinical studies conducted by Pharm-Olam in North America. Ensures adequate resources and training of all clinical personnel. Provide direct line supervision of local Clinical Research Managers (CRMs) and support to these individuals on a day to day basis.
Works across all departments to ensure a smooth working relationship between clinical and the other departments within Pharm-Olam. Oversees and ensures that all clinical staff are prepared for the timely set up, recruitment, management of sites, and completion of clinical studies that reflects quality performance and timely fulfilment of expectations. Oversees the quality and performance of clinical operational contractors and vendors within this region and responsible for their selection, review and management.
This is a full-time direct hire opportunity that is being recruited for throughout the US. Position can be remote.
- Direct all regional clinical operational activities arising or occurring within the designated region and liaise with other Directors of Clinical Operations and Clinical Operations Managers to ensure consistency, timeliness and quality of all study projects at Pharm-Olam.
- Manage Clinical Managers to ensure adequate mentoring of feasibility, site activation and clinical research personnel throughout the organization.
- Ensure adequate and sufficient resources for clinical operations in the region managing utilization, performance and productivity metrics.
- Working with the Training Department, ensure that appropriate training programs are available and attended; oversees and ensures assessment visits for new and ongoing personnel are completed with adequate and timely follow ups.
- Liaise regularly with Project Management for all clinical issues both personnel and project-related and to ensure that studies are adequately resourced and appropriately conducted.
- Ensures that SOPs and ICH GCPs are rigidly implemented in clinical trials conducted by Pharm-Olam and assists with the development and updating of clinical SOPs.
- Monitor and appraise the performance and compliance of the Clinical Managers in the region and subcontractors / vendors in conducting their agreed objectives and/or their contractual obligations.
- Organize task teams, to review current procedures and practices employed by Pharm-Olam and propose alternative or modified methods/techniques that are potentially more efficient, cost-effective, and/or improve the quality of clinical trials managed by Pharm-Olam.
- Plan and implement quality checks for clinical operations within the region.
- Ensures that feasibilities are conducted in a timely manner and works with Global Feasibility Unit and Business Development in the assessment and recommendation of countries.
- Participates in Request for Proposal and Request for Information processes
- Participate in Bid Defense Meetings – preparation and attendance (remotely or face to face)
- Other duties as assigned
- 10 years of experience working on clinical trials with 5-year experience in a leadership capacity; or equivalent combination of education, training and experience.
- Bachelor or higher university degree in life science, nursing or medical background preferred.
- Ability to travel as required both locally and internationally.
- Excellent knowledge of clinical trial management.
- Strong organizational skills and ability to deal with competing priorities, also strong reasoning and creative problem-solving skills.
- Advanced knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
- Strong leadership skills.
- Computer skills including proficiency in use of Microsoft Office 365 - Word, Excel, PowerPoint and MS Teams
- Strong written and verbal communication skills including good command of English.
- Effective communication, organizational, and interpersonal skills.
- Effective time management skills and ability to manage competing priorities.
- Ability to establish and maintain effective working relationships with co-workers, managers and clients.
- Occasional travel – 25 %.
Pharm-Olam, LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
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