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Form of workJob Description
This is a remote position.
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.
Your Role
We are hiring a Clinical Research Regional Monitor SeniorManager/Associate Director. This role will support our East Coast team/hours. This position will play a crucial role in ensuring the quality and compliance of clinical trials through effective management of research activities and responsible for overseeing team of monitors nationally.
- Provide leadership and oversight to clinical monitoring team.
- Serve as point of contact and liaison between sponsor and site monitors.
- Develop oversight processes and tools to maintain oversight of CRO field CRAs.
- Provide guidance for oversight activities across trial phases.
- Ensure adherence to regulatory requirements and protocols. Ensure the quality and integrity of clinical trial data by implementing robust monitoring processes.
- Conduct risk assessments, identifying potential risks and implementing effective mitigation strategies.
- Serve as point of escalation for all site teams and internal study teams.
- Lead team members to take appropriate actions on complex trial monitoring issues and review escalated monitoring visit reports.
- Collaborate with cross-functional teams to address and resolve quality issues.
- Collaborate with external vendors and partners involved in clinical monitoring activities.
- Provide technical guidance to teams for clinical trial conduct improvements including management of metrics, compliance, protocol deviations, and data entry.
- Oversee documentation, including monitoring plans, protocols, investigation site training materials, monitoring visit reports, etc.
- Reviewing case report forms for legibility, correctness, and adherence to protocol requirements.
- Additional responsibilities as required.
Requirements
- Bachelor's degree in relevant field.
- 5+ years of clinical monitoring experience with at least 3 years of experience managing Monitors, CRAs, etc.
- Experience in ophthalmology and oncology Clinical Research is preferred.
- Advanced knowledge of regulatory requirements and industry standards.
- Strong understanding of sponsor, site, and CRO processes and procedures.
- Proven success and ability in identifying risks and effectively implement mitigation strategies.
- Proven success in site management and monitoring.
- Excellent leadership skills with the ability to effectively communicate and collaborate across various teams and stakeholders.
- Strong organization and time management.
- Ability to provide timely and efficient follow up and guidance.
- Must be able to travel regionally to various sites.
Benefits
Offering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
- Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
- Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
- 401(k) and 401(k) matching
- PTO, Sick Time, and Paid Holidays
- Education Assistance
- Pet Insurance
- Discounted rate at Anytime Fitness
- Financial Perks and Discounts
Equal Opportunity Employment Statement
PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.
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