Clinical Trial Associate-Document Management Specialist

Clinical Trial Associate / Document Management Specialist

Transforming what patients can expect from cancer therapy takes passion and a strong dedicated team. When you join ADC Therapeutics, you will join a group of talented people who share this mission.

Why ADC Therapeutics

ADC Therapeutics (NYSE): is a commercial, global leader and pioneer in the field of antibody-drug conjugates (ADCs) with a constantly expanding technology toolbox. We are experts in the lifecycle of ADCs – starting with creation all the way through to commercialization. We have a robust pipeline of ADCS in Clinical Trials for both hematologic and solid tumor cancers. Our CD-19-directed ADC for relapsed/refractory non-Hodgkin lymphoma, ZYNLONTA® (loncastuxamab tesirine lpyl) has been approved in the United States and has also received European Commission approval. ZYNLONTA is also being evaluated in combination with other anti-cancer therapeutics to determine if it has potential to treat an even broader range of patients. We are a team of over 300 patient-focused, purpose-driven employees who carry out our mission in a flexible work environment. If you’re interested in making a difference in the lives of patients worldwide with a team of like-minded colleagues, come join us on our journey!

To learn more about ADC Therapeutics, please visit us at https://adctherapeutics.com/ and follow us on LinkedIn.

What You’ll Do:

The Clinical Trial Associate / Document Management Specialist is an important hybrid role that will assist the Clinical Operations Team by administratively supporting Clinical Trial Leaders in the operational execution of assigned clinical studies from planning to data delivery and study archive. Additionally, this role will successfully support the proper oversight, handling, and management of clinical study documents, related processes, and technology systems (e.g., eTMF, eDMS). This role may also aid in eSystem technology development and implementation if/when eSystems are brought in-house within ADCT.

The Clinical Trial Associate / Document Management Specialist position is remote based but will be affiliated with the New Providence, New Jersey office location and report to the Executive Director, Clinical Operations.

Clinical Trial Associate (~50% FTE):

• Assists with the development of critical study related documents, including but not limited to, clinical protocols, Informed Consent Forms (ICFs), operational documents, study reference documents, study newsletters, site materials, training materials, and other study related documents, as warranted
• Assists with the collection, review, tracking, and reporting of study related metrics and other critical information using various internal and external study trackers, databases, data forms, and reports (e.g., safety reports, recruitment metrics, project status)
• Assists with the oversight, review, and tracking of various required documents including but not limited to confidentiality agreements, feasibility and essential documents, and other regulatory materials; leverages the information in these documents to prepare regular and ad hoc reports that prompt initial and subsequent study supply releases
• Assists with the review, completion, submission, tracking and maintenance of site IRB/EC documents and reports
• Assists with the oversight and management of all TMF related audit activities including, but not limited to, completion of regular quality reviews, Corrective and Preventative Actions (CAPAs), reconciliation of Sponsor/CRO TMFs, and TMF archiving, as applicable; ensures all Trial Master File (TMF) related documents are properly obtained and filed in the applicable electronic system
• Supports the creation of Clinical Study Report (CSR) appendices and assists with the collection, appropriate document template and format and proper filing of related documents
• Assists with the creation, review, approval patient recruitment materials developed by internal and/or external parties
• Assists with external CRO and vendor management support, as needed
• Assists with the financial tracking of Clinical Trials, including but not limited to, site and vendor contracts, invoices, and payments
• Assists with the review, tracking and execution of study drug and other supplies and shipping related requests, drug accountability expiry lots, temperature excursion reporting and follow-up
• Assists with clinical sample receipt, shipment, and tracking, when applicable
• Assists with the training of internal and external clinical site personnel on various processes including, but not limited to, the study protocol, monitoring visits, systems, meetings, and other important documents and/or events
• Assists with the coordination, preparation, execution, and action-item follow-up of various study-related meetings including, but not limited to, clinical project, data monitoring, and safety meetings; drafts, reviews, disseminates, and files meeting agenda and minutes

Document Management Specialist (~50% FTE)

• Acts as SME and primary overseer/performer of document management activities related to eTMF (e.g., Phlex TMF) and eDMS (e.g., Master Control) which include, but may not limited to: document receipt, review, scanning, indexing, quality control, copying, filing, forwarding, return and/or archiving
• Ensures all study-related documents are properly obtained, reviewed, QCd, and filed in the eTMF
• Ensures proper and timely resolution of issues discovered and subsequent CAPAs initiated as a result of any audits, inspections, other
• Properly maintains study folders, files, systems as per applicable study plans, SOPs, and regulations
• Professionally liaises with internal and external study stakeholders, as needed, to fulfill eTMF and eDMS SME responsibilities
• Informs Clinical Trial Leaders and/or Clinical Operations Leadership of any document management, training, and/or quality risks and/or issues if/when identified with the aim of mitigating and/or resolving swiftly
• Remains knowledgeable and stays current on the TMF Reference Model and applicable TMF regulatory changes impacting document management processes and procedures
• Ensures eTMF Inspection Readiness
• Supports processes if/when potential eSystems are brought in-house (e.g., proposal development, review, selection, building, testing, training, implementation, oversight, management, decommissioning)
• Supports and tracks SOP development, review, and revision life cycle activities
• Acts as SME and assists with document workflows and document approval management via eDMS (e.g., Master Control)
• Assists with and supports other study document related and eSystem activities, as needed
• Assists with the selection, design, build, testing, go live processes, and data entry of specific system information that’s related to technology development and implementation

Who You Are:

• Bachelor’s degree or equivalent from an accredited college or university preferred; life Sciences degree preferred
• Minimum of 4-years of experience in supporting Clinical Trials in a Pharmaceutical /Bio-tech company, clinical setting, or health sciences experience; knowledge of the clinical research life cycle required
• Familiarity with medical terminology is necessary
• Ability to develop and track a variety of diverse project related data and documents and identify and manage to key performance indicators (KPIs), in a fast-paced, changing global environment is a must
• Proficiency in using Microsoft Suite (e.g., Word, Excel, Outlook, PowerPoint, Project) is a must
• Understand and have solid experience functioning as a SME in various technology eSystems (e.g., eTMF, eDMS) is a must
• Experience with successfully overseeing, maintaining, tracking, and reporting within an electronic Trial Master File is a must
• Experience with supporting internal, external Audits/Inspections is preferred
• Experience in supporting quality management activities, SOP tracking is preferred
• Excellent oral and written English communication skills
• Ability to present technical information in a concise and clear manner
• Attentive to detail as well as excellent time management, organization, oral and written English communication skills is required
• Ability to flex and help support activities that aim to resolve unanticipated environmental changes and unforeseen trends is required
• Ability to present various information in a clear and concise manner and work in cross-functional teams and in a highly matrixed manner
• Willingness to travel 10-20%

ADC Therapeutics is proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/ProtectedVeterans/Disabled. We are committed to building diverse teams and fostering an inclusive, professional, and respectful work environment where employees are empowered for success.