Clinical Documentation Specialist (Gcp Qa)

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation and biology to discover novel treatments for life-threatening disease. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins of proteins as drug targets.

Position

We are currently recruiting a Clinical Documentation Specialist, Clinical GCP Quality Assurance who is responsible for supporting the development and maintenance of Eikon Therapeutics procedural documents used in the conduct of clinical research studies. The Clinical Documentation Specialist, Clinical GCP Quality Assurance is also responsible for gathering metrics and KPI data which contributes to reports for senior management on the overall state of quality at Eikon Therapeutics.

About You

You are someone extremely detail-oriented and enjoy managing a variety of tasks simultaneously. You work well with others and have a good understanding of the importance each person/function brings to the procedural document process. You can see the “big picture” of how the procedural documents contribute to the quality of the clinical research process.

What You’ll Do

• Perform quality control reviews, edit and format, of controlled documents and written procedures against internal standards.
• Establish and maintain curricula and learner roles in Veeva Vault training; create training requirements and release training assignments.
• Participate in system upgrades and or configuration changes as required.
• Maintain a matrix of required training for all employees and ensure employees have required training records including CVs on file for purpose of Health Authority Inspection.
• Track and manage all PDs (and PD deviations) to ensure timely processing of new PDs or revision of existing PDs; track and manage job aids (e.g., Quick Reference Guides).
• Ensure that new hires are assigned training to appropriate learner role(s).
• Collaborate with IT representatives to ensure Veeva clinical system remains in a steady state in terms of PDs loaded into the system. Serve as a support role to end users with basic system related questions.
• Collaborate with document authors on the maintenance of existing Procedural Documents (PDs); update and maintain training matrix, Standard Operating Procedure (SOP) Glossary, and SOP template.
• Provide input to functional leads for the purpose of defining functional training matrices.
• Collaborate closely with Process, Documentation and Learning Management function, as required.

Qualifications

• Strong project management; exhibits expertise in metrics analysis and reporting methodologies.
• 5+ years of experience in clinical documentation management.
• Bachelors degree or equivalent is required.
• Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with stakeholders.
• Demonstrated knowledge on Microsoft Office skills and well versed in industry trends and emerging technologies supporting documentation practices.
• Experience with Veeva preferred.
• Sound working knowledge of Good Clinical Practice (GCP).
• Excellent oral and written skills with all levels of the organization.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs including:

• Weeklong summer and winter holiday shutdowns
• Daily subsidized lunch program when on site
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
• Generous paid time off and holiday policies
• Medical (premiums covered by Eikon at 95%). Dental and vision insurance (premiums covered by Eikon at 100%)
• Mental Health and Wellness benefits
• Enhanced parental leave benefit
• 401 plan with company matching

The expected salary range for this role is $107,000 - $123,000 depending on skills, competency and the market demand for your expertise.