- Clinical Study Management: Take a lead role in the planning, implementation, and management of clinical studies from Phase 1 to Phase 3. Ensure that studies are conducted in accordance with applicable regulations, guidelines, and protocols. Coordinate study activities, including stie selection, study initiation, patient recruitment, data collection, and study close-out.
- Vendor Management: Oversee and manage relationships with CROs and other third-party vendors involved in the clinical trial planning and execution. Participate in vendor selection for services such as bioanalysis, data management, and other study-specific needs.
- Protocol Development: Contribute to the development of clinical study protocols, collaborating with cross-functional teams to ensure that protocols are scientifically sound, feasible, and compliant with regulatory requirements. Provide input on study design, objectives, endpoints, and patient eligibility criteria.
- Clinical Document Review and Writing: Assist in the review and writing of clinical documents, including but not limited to study protocols, investigator brochures, informed consent forms, case report forms, and clinical study reports. Ensure that documents are accurate, complete, and adhere to regulatory guidelines.
- Data Monitoring: Monitor study data remotely, on-site, or through approved modes, with a focus on data integrity and patient safety. Ensure compliance with specific country regulations governing clinical trials. Identify and address data discrepancies and protocol deviations in a timely manner.
- Site Staff Training: Provide training to site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion. Ensure that site staff are knowledgeable and adhere to good clinical practice (GCP) guidelines throughout the study.
- Study Monitoring and Visits: Play day-to-day activities for study monitoring and set priorities for site visits. Lead the team in conducting qualification, study initiation, interim monitoring, and close-out visits at investigator sites. Maintain regular contact with investigator sites between visits.
- Timeline and Budget Adherence: Ensure adherence to study timelines and budgets by closely monitoring project milestones, resource allocation, and expenses. Identify and address any delays or budgetary concerns promptly and implement appropriate corrective actions.
- Bachelor of Science or equivalent degree, required.
- Advanced degree preferred.
- 5+ years of experience of global clinical trial operation in biopharmaceutical companies.
- Experience in global phase 1-3 clinical trials in autoimmune diseases, strongly preferred.
- Comprehensive knowledge of clinical trial regulations, guidelines, and best practices, including ICH-GCP.
- Successful track record in study planning, country/site selection and activation, patient recruitment and retention, data cleaning, and data base lock.
- Strong project management skills with the ability to prioritize tasks and meet deadlines.
- Detail-oriented with a focus on data integrity and patient safety.
- Proficiency in using clinical trial management systems and electronic data capture systems.
- Excellent written and verbal communication skills.
- Ability to work cross-functionally in a fast-paced, collaborative environment.
- Strong attention to detail and problem-solving skills.
- 401(k) and matching program
- Medical, Vision, and Dental Insurance
- Flexible Spending Account
- Short- and long-term disability
- Life insurance
- Employee Assistance Program
- Employee discounts
- Paid time off/vacation/sick time
- Professional development assistance
- Referral program
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Clinical Trial Manager, Autoimmune - South San Francisco, United States - Remegen Biosciences, Inc.
Description
Job Description
Job DescriptionORGANIZATION
RemeGen Biosciences is a biopharmaceutical company, focusing on the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases, based in South San Francisco, California, and Rockville, Maryland. By leveraging our deep insights into oncology and immunology, advanced protein engineering/design technologies, and extensive knowledge in clinical development, our vision is to uncover the novel therapeutic targets and develop the best-in-class and first-in-class biotherapeutics for the patients with significant unmet medical needs. RemeGen Bioscience is a wholly owned subsidiary of RemeGen Co., Ltd a global pharmaceutic company specialized in autoimmune, oncology and ophthalmic diseases.
POSITION SUMMARY
As a Clinical Trial Manager/Sr. Manager, you will be responsible for overseeing and managing clinical studies, ensuring the successful execution of trials, and maintaining compliance with regulatory guidelines. Your key responsibilities will include preparing and managing clinical studies, managing third party vendors and Contract Research Organizations (CROs), contributing to protocol development, monitoring data integrity and patient safety, and ensuring adherence to study timelines and budgets. This is a remote role open to candidates in Massachusetts, Pennsylvania, South Carolina, and Texas.
KEY RESPONSIBILITIES
REQUIREMENTS
Education:
Experience:
Skills:
BENEFITS
Benefits:
RemeGen Biosciences is an Equal Opportunity Employer. RemeGen Biosciences' success depends heavily on the effective utilization of qualified people, regardless of their race, ancestry, religion, color, sex, age, national origin, sexual orientation, gender identity and/or expression, disability, veteran's status, or any other characteristic protected by the law. As a company, we adhere to and promote equal employment opportunity (EEO) for all.
Must be able to work legally in the United States without sponsorship from employer.
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