Senior Clinical Trial Associate

Opportunity for Secondment to AskBio

Were pleased to share an exciting secondment opportunity at AskBio. This role is available for a time period to be determined by leadership at both Bayer and AskBio. While most assignments range from one to two years the exact duration will be based on business needs and mutual agreement.

This secondment offers a unique chance to broaden your experience expand your knowledge and contribute meaningfully to AskBios mission: to advance gene therapy and change the lives of patients around the world.

If youre interested in exploring this opportunity we encourage you to:

• Speak with your direct manager to discuss your interest and alignment with your development goals.

• Apply directly using the link provided in the posting.

We look forward to seeing how our colleagues continue to grow and make an impact across the Bayer-AskBio partnership.

Our vision: Pioneering science to create transformative molecular medicines.

Our mission: Lead innovative science and drive clinical outcomes to transform peoples lives.

Our principles:

Position Summary

TheSenior Clinical Trial Associate reporting to the Director Clinical Operations will be responsible for supporting the creation and maintenance of paper and/or electronic clinical trial records including the Trial Master File (TMF) with a focus on maintaining inspection readiness throughout the lifecycle of an individual clinical trial or a clinical development program. This position is an integral part of the study/trial team in assuring that all clinical trial paperwork is handled appropriately and that assigned TMFs are complete accurate and timely. This is a US-based remote position.

Job Responsibilities

• Support the Clinical Trial Manager(s) and overall study team for all phases of study conduct (feasibility planning and start up conduct/maintenance and closeout).

• Assist with maintaining study status updates on agreed cadence (examples of activities tracked include IRB approvals regulatory document collection patient enrollment monitoring status).

• Provide support for inspection readiness by formatting proofreading documents and contributing to the establishment maintenance and quality control of the TMF (maintained internally or by CROs).

• Assist clinical trial managers (CTM) with preparation handling distribution and tracking of clinical trial supplies and other study supplies.

• Prepare and maintain investigator information tracker for clinical trial operations working with employees or vendors.

• Support compilation of documentation for CSR appendices based on clinical trial protocol and clinical study report (CSR) requirements.

• Assist in the development of the structure of TMF and filing system and supports study team in maintaining up to date study documents and assist with or independently conducts Quality Control review of in house or vendor TMF(s).

• Create Metrics Reports to assist with trial oversight and to demonstrate quality and completeness of the TMF as well as other study documents.

• Assist with planning organization and conduct of external meetings such as Investigator Meetings.

• Review regulatory documents to ensure completeness in accordance with Sponsor requirements ICH/GCPs CFR EMA MHRA and other health authority requirements/regulations.

• Organize and provide oversight of study contracts budget documents billing and invoices supports study team to process all study financial documents to ensure timely processing payment and tracking and assists with budget reconciliation.

• Coordinate timely resolution of document issues with the documents from study sites data management centers and other trial collaborators.

• Generate regulatory compliant Certified Copies.

• Support compilation of documentation for CSR appendices based on clinical trial protocol and clinical study report (CSR) requirements.

• Assist in the development of the structure of TMF and filing system and supports study team in maintaining up to date study documents and assist with or independently conducts Quality Control review of in house or vendor TMF(s).

• Create Metrics Reports to assist with trial oversight and to demonstrate quality and completeness of the TMF as well as other study documents.

• Assist with planning organization and conduct of external meetings such as Investigator Meetings.

• Review regulatory documents to ensure completeness in accordance with Sponsor requirements ICH/GCPs CFR EMA MHRA and other health authority requirements/regulations.

• Organize and provide oversight of study contracts budget documents billing and invoices supports study team to process all study financial documents to ensure timely processing payment and tracking and assists with budget reconciliation.

• Coordinate timely resolution of document issues with the documents from study sites data management centers and other trial collaborators.

• Generate regulatory compliant Certified Copies when needed

Minimum Requirements

• Masters Degree and 3 years experience in clinical trial support OR Bachelors Degree and 5 years experience in clinical trial support OR High School Diploma and 9 years relevant experience

• Prior experience setting up and managing study and/or program level tracking processing contracts/resultant invoices for payment/tracking.

Preferred Education Experience and Skills

• Significant knowledge of the drug development process relevant regulatory requirements for drug approval and documentation required for Inspection Readiness.

• Familiarity and experience with clinical trial Records Management and TMF requirements and practices.

• Strong understanding of TMF requirements/practices.

• Excellent verbal and written communications skills; able to communicate proactively and effectively to build successful working relationships with internal and external stakeholders.

• Attention to detail highly organized and the ability to multitask and prioritize in a fast-paced highly interactive environment.

• Proficiency in Microsoft Office Suite (Word Outlook Excel PowerPoint).

AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race color religion gender sexual orientation gender identity national origin age disability veteran status or any other protected status prohibited under Federal State or local laws. All employment decisions are based on valid jobrelated requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website you may request a reasonable accommodation to express interest in a specific opening by calling us at or sending us an email at .