Associate Director, Clinical Data Management

Position

We are currently recruiting an Associate Director, Clinical Data Management who is responsible for timely and high-quality data management deliverables supporting the Eikon portfolio. The Associate Director, Clinical Data Management is also responsible for leading or contributing to company process improvement initiatives, vendor performance assessment and governance of clinical data standards. This position requires the ability to function and lead in a fast paced and dynamic environment and may have line management responsibility.

About You

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(s) 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/external study team members and stakeholders.
• Provides strong quality and project oversight over third party vendor(s) responsible for data management deliverables.
• Takes a leadership role to gather content and integration requirements for EDC and ensuring close collaboration/alignment with partners supporting other data collection systems (eCOA, External Data, RTSM, etc.). Enforces data standard conventions and ensures high quality expectations for all clinical data per defined processes & best industry practices.
• Authors, reviews/revises clinical data managment 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 Data Management on cross-functional project teams & submission teams.
• Lead or support the Health Authority inspections and audits as relates to Data Management activities.
• 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), as required.
• Define, manage and govern clinical data standards in accordance with CDASH principles and best practices.
• Responsible for managing clinical data management staff, as assigned, including training, mentoring, goal setting, performance management and engagement.

Qualifications

• 10 years of experience and a Bachelor’s degree, or 8 years of experience and a post graduate degree.
• Proven 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.
• Experience managing non-EDC data sourced from laboratories, eCOA and IRT.
• Strong project management; exhibits expertise in metrics analysis and reporting methodologies.
• Good understanding of coding (MedDRA, WHO drug dictionaries).
• Excellent oral and written communication skills, with all stakeholder levels.
• 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 $174,000 to $190,000 depending on skills, competency, and the market demand for your expertise.

Salary : $174,000 - $190,000