Senior Clinical Data Management Programmer
4 weeks ago
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 diseases. 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 as drug targets.
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-siteThe expected salary range for this role is $130,000 to $142,500 depending on skills, competency, and the market demand for your expertise.
Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
In accordance with the Company’s duty to provide and maintain a safe workplace, the Company requires all employees to be Fully Vaccinated with one of the FDA approved COVID-19 vaccines, which includes those vaccines that have received the FDA’s emergency use authorization. You will be expected to be Fully Vaccinated as of your Start Date. If you believe that you are exempt from this requirement under an applicable law or regulations, including Americans with Disabilities Act and California’s Fair Employment and Housing Act, you will need to contact the Company’s Human Resources group. For purposes of this section, Fully Vaccinated means (i) the completion of the vaccination regimen as approved by the FDA (by way of example, 2 doses of the Pfizer or Moderna vaccine and 1 dose of the Johnson and Johnson vaccine), and (ii) timely receiving booster vaccination, as recommended by the Centers for Disease Control and Prevention.
We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.
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