Job Overview:
Pay Range: $70.64hr - $75.64hr
Requirement/Must Have:
- Degree (MD, PhD, MA/MS, BA/BS) in life sciences or equivalent.
- Postgraduate degree or master’s degree highly desirable.
- Demonstrated experience in clinical trial start-up, regulatory submissions, and cross-functional collaboration.
- Strong understanding of ICH-GCP, EU CTR, and local regulatory environments.
- Experience managing vendor/CRO relationships.
- Proven leadership or line management experience.
- Proficiency in clinical systems such as Veeva Vault, CTIS, and RIM.
- Strong verbal and written communication skills.
- Excellent communication and presentation skills.
Responsibilities:
- Drive and facilitate efficient study start-up processes to contribute to the delivery of clinical trials.
- Enable innovative clinical trial delivery and address study start-up needs across various therapeutic areas.
- Collaborate with local internal and external country teams, global study teams, and CROs.
- Develop and implement effective start-up strategies and oversee start-up operations.
- Drive process improvements at the country and site level while maintaining regulatory compliance.
- Lead the country strategy for study start-up, driving efficiency and innovation.
- Ensure timely and efficient site activation and alignment with global strategies and timelines.
- Manage amendments throughout the study lifecycle.
- Identify and drive opportunities for process automation, standardization, and innovation.
- Collaborate with regional and global counterparts to harmonize systems and improve timelines.
- Participate in external industry collaborations to influence country start-up environments.
- Engage with government and institutional bodies to align on clinical trial policies and practices.
- Lead teams in the creation of study start-up strategy and execution, including proactive risk mitigation and stakeholder liaison.
- Architect and strategically oversee Informed Consent Form (ICF) management, including preparation, submission, and archiving.
- Lead the development and oversight for clinical trial submissions, amendments, and regulatory coordination.
- Strategically manage site documentation and compliance, including document collection and validation.
- Oversee translation and approval of drug labels and patient-facing materials.
- Maintain up-to-date knowledge of country-specific regulations for medicinal products, medical devices, and IVDRs.
- Provide strategic planning and implementation for budgeting and contract management.
- Develop Fair Market Value-based budget strategies and draft clinical site budgets.
- Negotiate and implement contracts, confidentiality disclosure agreements, and indemnity/insurance documentation.
- Oversee payment processes, escalations, and reporting to ensure financial and regulatory contract compliance.
Nice to Have:
- Postgraduate degree or master’s degree.
Skills:
- Clinical trial start-up.
- Regulatory submissions.
- ICH-GCP.
- EU CTR.
- Vendor management.
- CRO management.
- Veeva Vault.
- CTIS.
- RIM.
- Budgeting and Contract Management.
- Informed Consent Form (ICF) Management.
- Stakeholder Management.
- Analytical and problem-solving capabilities.
Qualification And Education:
- Degree (MD, PhD, MA/MS, BA/BS) in life sciences or equivalent.
Benefits
Our Benefits Include:
- Medical, Dental, and Vision Insurance
- 401(k) Retirement Plan
- Health Savings Account (HSA)
- Disability Insurance (Short-Term and Long-Term)
- Life and AD&D Insurance
- Paid Sick Leave (where required by applicable state or local law)
- Supplemental Insurance Plans
- Identity Theft Protection
- Pet Insurance
- Employee Wellness Programs
- Employee Assistance Program (EAP)
- Career Growth and Professional Development Opportunities
Disclaimer: Benefits eligibility, accrual rates, and usage limits may vary based on employment status, length of service, and work location. Paid Sick Leave is provided in strict accordance with applicable state and municipal mandates. Cynet Systems Inc. reserves the right to modify, amend, or terminate any benefit plans at any time in accordance with applicable laws.
About Cynet Systems
Founded in 2010 and headquartered in the Washington, DC metro area, Cynet Systems Inc. is a leading technology staffing and workforce solutions company serving Fortune 500 companies, government agencies, and enterprise organizations across the United States and Canada. We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and professional staffing, powered by a high-performing recruitment engine operating across North America and Asia.
As a nationally and locally certified Minority Business Enterprise (MBE), Cynet Systems is committed to helping organizations build high-performing teams while empowering professionals to grow rewarding careers. Our organization is certified to ISO 9001, ISO 14001, ISO 27001, and SOC 2 Type II standards, reflecting our commitment to quality, security, operational excellence, and customer success.