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Clinical Trial Regulatory Specialist
2 months ago
Join us at Lifelancer as we unite caring with discovery to make life better for people around the world.
About UsLifelancer is a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work together to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.
Clinical Trial Responsibilities- We are seeking a Clinical Trial Regulatory Specialist to ensure submission and approval of high-quality regulatory applications within planned timelines and facilitate interactions with regulatory bodies on a regular basis for approvals.
- The ideal candidate will initiate Investigator site(s) in collaboration with Asia-Pacific Trial Capabilities personnel, including monitoring of clinical trial regulations and requirements, providing consultation for effective communication with Competent Authority (CA) and relevant parties in addressing any validation questions on the clinical trial dossiers and resolving any barriers to approval.
- This role ensures country-specific regulatory and data privacy requirements are communicated to Asia Pacific Trial Capabilities personnel for incorporation into submission documents and any other documents/systems.
- The successful candidate will ensure that Clinical trial activities comply with local regulations and quality system requirements whichever is more stringent.
- They will anticipate and monitor dynamically changing regulatory requirements.
- The individual will lead and participate in global Clinical system-related projects.
- Responsibilities include managing ERB/CA submission and site readiness activities involving distributing and collecting hard-copy documents.
- The Clinical Trial Regulatory Specialist will serve as the local point of contact for Trial Capabilities-related activities that have to be managed locally, including meeting with sites, ERBs, and CAs for trial-related discussions; communicating with Site Engagement and external parties/cROs to enable active collaboration during site activation, maintenance, and close-out.
- The individual will identify, communicate, and resolve issues, escalating them to aligned management and quality as appropriate.
- They will coordinate the management and delivery of clinical trial materials to ensure support of site initiation.
- The Clinical Trial Regulatory Specialist will populate internal systems to ensure accuracy of trial/site performance and populate Trial Master Files and libraries for future reference.
- The role requires anticipating and monitoring dynamically changing priorities.
- The individual must understand, comply, and reinforce local regulations and guidelines, Lilly Medical policies and procedures, and good clinical practices (GCP).
- A bachelor's degree preferably in a scientific or health-related field.
- At least two years of previous clinical trial regulatory experience or relevant experience.
- The ideal candidate will have an understanding of the overall clinical development paradigm and the importance of efficient site activation.
- Applied knowledge of project management processes and skills.
- An appreciation of compliance-driven environments.
- Ability to learn and comply with financial and legal guidelines and policies (budget and contract).
- Effective communication, negotiation, and problem-solving skills.
- Self-management and organizational skills.
- Language capabilities: English (read, write, conversation) and local language, as applicable.
Lifelancer does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.
About the RoleThis is an exciting opportunity to join a dynamic team and contribute to the success of clinical trials. The estimated salary for this role is approximately ₹1,200,000 - ₹1,500,000 per annum, depending on qualifications and experience. If you are passionate about making a difference in the lives of others, please apply via the link below:
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