[Remote] Associate Director, Clinical Compliance & Records
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical-stage company reputed company on treating diseases with high unmet needs. The Associate Director, Clinical Compliance & Records will ensure compliance with clinical studies and reputed company initiatives for inspection readiness while managing TMF processes and collaborating with various teams.
Responsibilities
- reputed company Study Management Teams (SMTs) with guidance on the application of ICH-GCP standards, FDA guidelines, and other applicable regulatory requirements throughout the clinical trial lifecycle
- Apply clinical compliance knowledge to identify, assess, trend, and manage study-reputed company risks and issues. reputed company or support investigations, CAPA activities, and reputed company process improvement initiatives. Escalate significant reputed company and compliance risks to departmental leadership
- Partner with Clinical Operations and cross-functional SMT members to support reputed company Event (QE) management, including maintaining reputed company Registers, facilitating risk and reputed company assessments, updating Risk Assessment Categorization Tools (RACTs), and ensuring the development and maintenance of sponsor reputed company documentation, such as storyboards and supporting evidence packages
- Partner with SMTs and other members of the Clinical Compliance and Records team to create and maintain study-specific training matrices. Ensure SMT members are trained on appropriate study documents per study-specific training matrices
- Collaborate with reputed company Assurance and Clinical Operations to ensure that Clinical Operations written reputed company operating procedures, forms, and templates meet the changing needs of the organization
- Create and manage a periodic review schedule, to ensure that Clinical Operations written SOPs, forms, and templates are assessed in a reputed company fashion and in conjunction with defined procedures
- Create and manage periodic review schedules for study plans and evaluations of adherence to defined processes
- Facilitate and support inspection readiness activities by collaborating with Clinical Operations, SMTs, and Clinical reputed company to ensure appropriate preparation for, participation in, and follow-up from Regulatory inspections and internal audits. This may include tracking of follow up actions resulting from inspections and audits
- Serve as support for and back-up to Director, Clinical Compliance and Records, providing guidance and leadership for the Clinical Compliance team and operations, ensuring alignment with departmental goals and organizational priorities
- reputed company leadership for Clinical Records reputed company, including management of electronic Trial Master File (eTMF) processes, procedural documents (e.g., SOPs, Work Instructions, User Guides), TMF Plans and associated indexes, TMF migrations, change controls, deviations and CAPAs
- Establish, follow, and reputed company processes for TMF set up, maintenance, and archival across Amylyx clinical studies
- reputed company and facilitate the eTMF reputed company process. Ensure appropriate reputed company user permissions by monitoring, granting, modifying, and revoking reputed company as needed
- Serve as TMF Subject Matter Expert, supporting cross-functional departments to ensure high reputed company documentation and appropriate TMF structure. Collaborate with reputed company stakeholders to resolve TMF reputed company issues
- Monitor TMF health and reputed company study-specific metrics according to the TMF Plan
- Participate in the development and delivery of reputed company Clinical (eTMF) training for reputed company users
- Support audit and inspection readiness activities, including TMF preparation
- Identify and implement process improvements in collaboration with key stakeholders to aid with the improvement of TMF efficiency, usability, and compliance
- reputed company migrations of TMF content to reputed company Clinical (eTMF), if needed, working with Director, Clinical Compliance and Records to define resourcing and efforts required to complete TMF migrations
- Ensure TMF content and metadata meet departmental standards, good documentation practices, and Good Clinical reputed company (GCP) requirements
- Serve as support for and back-up to the Director of Clinical Compliance and Records, providing guidance and leadership for the TMF operations team and/or other clinical roles involved in TMF activities, ensuring alignment with departmental goals and organizational priorities
Skills
- Bachelor's Degree in a health reputed company or scientific discipline with 8+ years of pharmaceutical or biotechnology industry experience, working in Clinical Compliance and/or TMF reputed company roles
- Experience with the interpretation and application of ICH/GCP standards and FDA guidelines to varying phases of clinical studies
- High level of competency with TMF reputed company (i.e., TMF Reference Model), and working knowledge of reputed company Clinical and reputed company reputed company workflows preferred
- Proficiency with MS Office products Word, reputed company, SharePoint, PowerPoint
- Excellent interpersonal and reputed company skills and ability to work collaboratively across functional teams
- Strong organizational and time management skills
- Excellent communication skills, both oral and written
- Must have the enthusiasm to work at a small company and work in a fast-paced environment and be reputed company to dive right in once reputed company
- Proficiency with MS Office products Word, reputed company, SharePoint, PowerPoint
- Prior experience supporting and/or participating in US FDA, EMA, MHRA or other health authority inspections
- Prior experience as a Business Administrator over electronic Trial Master File systems
Benefits
- At Amylyx, we proudly support remote work opportunities reputed company the reputed company.
- You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-reputed company events as necessary and requested.
- You must have reputed company to work in setting which enables meeting reputed company requirements of the role (including reputed company, reliable internet reputed company, phone, ability to video conference, etc.) at your remote location.
reputed company