Title: Senior Clinical Trial Associate

Location: Durham United States

Job Description:

Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that can potentially cure genetic diseases has never wavered.

At AskBio, we've built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson's disease, and congestive heart failure. Our gene therapy platform includes Pro10, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.

We became a wholly-owned, independently operated, subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform. Our global headquarters is in Research Triangle Park, NC. Additionally, we have significant operations in Philadelphia, PA, Columbus, OH, Scotland, France, Germany, and Spain.

Our vision: Pioneering science to create transformative molecular medicines.

Our mission: Lead innovative science and drive clinical outcomes to transform people's lives.

Our principles:

Advance innovative science by pushing boundaries.

Bring transformative therapeutics to patients in need.

Provide an environment for employees to reach their fullest potential.

Our values:

Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.

Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.

Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.

Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.

Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what&#39;s right in every situation. Make clear commitments and follow through.

Position Summary

The Senior 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, hybrid schedule position, allowing for a blend of remote work and in-office presence at our Research Triangle Park, NC or Philadelphia, PA headquarters.

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

Master&#39;s Degree and 3+ years&#39; experience in clinical trial support OR Bachelor&#39;s Degree and 5+ years&#39; experience in clinical trial support OR High School Diploma and 9+ years&#39; 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).

Asklepios BioPharmaceutical, 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 job‐related 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 (919) 561-6210 or sending us an email at careers@askbio.com.

Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.

Asklepios BioPharmaceutical - AskBio

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