Position

We are currently recruiting a Senior Clinical Data Management Programmer within our Data Management Group. This role is responsible for the effective development of study level EDC databases, reports/dashboard, and system integration support. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our California, New York or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

About You

You are a driven individual that focuses on detail. An expert in data management and a strong collaborator.

What You’ll Do

• Building, maintaining, and deploying study databases to collect clinical trial data, including configuring study database internal module connections and external system integrations. Being responsible for initial study database development and changes required after initial deployment. Taking responsibility for more complex studies in the portfolio which may require additional expertise.
• Building the reports/dashboard for data management and clinical team for data review.
• Contributing to the development of appropriate timelines for development and deployment of study databases.
• Providing EDC technical expertise to Data Management and to the clinical study team members to support study decisions.
• Managing work assignments to ensure timely delivery.
• Identifying and resolving issues which may negatively impact delivery of work, using collaborative strategies to reach resolution. Escalating issues to leadership appropriately.
• Following procedural documents and participating in reviewing and updating documents to make sure they are reflective of industry standards and regulatory requirements and include optimal processes.
• Training and/or mentoring newer EDC Database Development team members on key activities and processes.
• Contributing to the development and application of smart systems and optimal approaches to support the collection of data.
• Supporting preparations and follow-up actions related to Health Authority inspections and internal audits.
• Provide the relevant support to setup and validate standard global library.

Qualifications

• PhD without experience, or a Masters Degree plus 3 years of relevant experience, or a Bachelors Degree and 5 years of relevant experience. 
• Proven global clinical trial expertise with a focus on EDC database development.
• Clinical database development experience in Veeva will be preferred.
• Proven experience of reports/dashboard development (SAS, and JReview/Spotfire) is required.
• Solid understanding of the drug development process with proven expertise in clinical trial start-up/execution and EDC database development.
• Strong knowledge of industry leading EDC tools (e.g., Veeva CDMS, Medidata Rave, Oracle/Inform, etc.) and well versed in industry trends and emerging technologies supporting data collection.
• Strong knowledge of clinical study design.
• Strong knowledge of GCP/ICH guidelines.
• Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.
• Understanding of database and dictionary structures (e.g. MedDRA, WHODrug).
• Experience with CDISC standards including CDASH and SDTM is desirable.
• Demonstrated partnership across various collaborative forums.
• Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality etc.).
• Demonstrated ability to self-start, be solution-oriented, collaborate effectively with stakeholders, drive activities to completion, and be accountable for results.

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

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

The expected salary range for this role is $130,000 to $142,500 depending on skills, competency, and the market demand for your expertise.