Clinical Document Specialist

COMPANY:

At BioCryst, we share a deep commitment to improving the lives of people living with complement-mediated and other rare diseases. For over three decades we’ve been guided by our passion for not settling for “ordinary” in our quest to develop novel medicines. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and protein therapeutics, led by the efforts of our team of expert scientists in our Discovery Center of Excellence in Birmingham, Alabama. Our global headquarters is in Durham, North Carolina, our European headquarters is in Dublin, Ireland and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at www.biocryst.com or follow us on LinkedIn and Instagram. 

JOB SUMMARY:

The Clinical Document Specialist is responsible for creation, periodic review, and maintenance of BioCryst Trial Master Files (TMF) in accordance with Standard Operating Procedures (SOPs), GCP and ICH Guidelines to ensure inspection readiness. This individual should be experienced and proficient in set-up, indexing, tracking, and filing documents in paper and electronic TMF (eTMF) systems for clinical trials, ranging in size and complexity from Phase I through IV, single site to global multi-center trials.

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Assist with the setup, organization, and quality maintenance of trial specific TMFs and SharePoint sites.
• Assist with the filing and archiving of clinical documentation in accordance with SOPs.
• Assist with Contract Research Organization (CRO) oversight and review of regulatory packages for trial-related submissions to Health Authorities and IRB/IECs and/or clinical supply release.
• Conduct periodic review of TMFs, both internally and those managed by external CRO vendors, in accordance with SOPs. Identify and raise quality issues on clinical documents and follow them to resolution of deficiencies.
• Establish and maintain effective communication and collaboration with functional area colleagues, e.g., Regulatory Affairs, Clinical Quality Assurance, Data Management, Biometrics, Global Drug Safety and Pharmacovigilance, Global Development, Clinical Supply Chain, and CROs in order to ensure up-to-date, high quality, inspection ready TMFs.
• Become a subject matter expert on BioCryst’s standard TMF Index. Routine review of TMF Index in collaboration with Veeva Administrator, Clinical Trial Leads, and functional area colleagues to ensure guidance on filing of all clinical documentation remains current.
• Maintain inventory reports and tracking systems for archived paper files to ensure files are recallable from off-site storage facilities in a timely and efficient manner.
• Provide support in the preparation, conduct and follow-up of audits and inspections.
• Review regulatory packages for trial-related submissions to Regulatory Authorities and IRB/IECs or clinical supply release.
• Manage and maintain clinical trial training documentation.
• Prepare and distribute clinical trial team meeting minutes.
• Must be able to work independently, adapt to changing priorities, with the ability to take initiative to complete tasks accurately and timely.
• All other duties as assigned.

EXPERIENCE & QUALIFICATIONS:

• BA or BS with at least 2 years of clinical trial experience gained ideally in a Sponsor and/or CRO role or an equivalent combination of education and experience.
• Hands-on experience with supporting one or more clinical programs at a given time.
• Knowledge of Good Clinical Practice (GCP) regulatory requirements and International Conference on Harmonization (ICH) guidelines.
• Ability to understand scientific literature.
• Ability to identify team needs and suggest/implement solutions for improved departmental functionality.
• Must be a highly motivated self-starter who can take initiative and sees projects through to completion with minimal supervision.
• Strong organization and interpersonal skills and the ability to manage and cultivate relationships.
• Ability to communicate effectively internally and externally.

 

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this