- Job Type: Full-Time
- Function: Clinical Research
- Industry: Biotechnology
- Post Date: 02/15/2024
- Website: eikontx.com
- Company Address: 3929 Point Eden Way, Hayward, CA 94545
About Eikon TherapeuticsEikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the interface of biology, engineering and chemistry 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.
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.
We are currently recruiting a Senior Manager, Data Management who is responsible for timely and high-quality data management deliverables supporting the Eikon portfolio.
You are a driven individual that focuses on detail. An expert in data management and a strong collaborator.
What You’ll Do
- Provides clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects
- Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects
- Responsible for end-to-end clinical data management activities and serves as a primary point of contact for internal and external study team members
- Provides strong quality and project oversight over third party vendor responsible for data management deliverables
- Takes a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (eCOA, External Data, RTSM). Enforces data standard conventions and quality expectations for clinical data per defined processes
- Authors, reviews/revises DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization
- Chairs Data Review meetings with cross functional study team members to ensure on-going review of trial data currency, quality and completeness
- Represents DM on cross-functional project teams & submission Teams
- Lead or support the Health Authority inspections and audits.
- Provides coaching and quality oversight of junior Data Management Leads
- Act as core member of the study team and provides FSP/CRO/Vendor oversight for end-to-end Data Management activities, manages data currency throughout the trial, and overall monitoring DM deliverables according to the Service Level Agreement (SLA)
- Lead/provide the relevant support to set up, validate the standard eCRF library
- A Bachelor’s degree, or equivalent is required.
- 5+ years of experience in clinical data management gained from working at recognized clinical data management suppliers/vendors, reputable CRO(s) and/or a Sponsor environment working on multi-phase, multi-therapeutic (Oncology experience will be preferred) and diverse clinical trials from study initiation to completion and associated regulatory submission and inspection preparation.
- Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors.
- Sound knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management
- Strong knowledge and experience of EDC systems (Veeva CDMS preferred); demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collection.
- Strong project management; Exhibits expertise in metrics analysis and reporting methodologies.
- Excellent oral and written communication skills
- Communicate effectively with senior management and cross-functional teams.
- Deep knowledge of CDASH/CDISC (CDASH CRF Library implementation experience is preferred)
- Knowledge of submission requirements, [e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA)]
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 $135,000 to $155,000 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.