Senior Manager, Clinical Data Management at Eikon Therapeutics

Jersey City, New Jersey, United States

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, Clinical ResearchIndustries

Requirements

Post Graduate degree with 6+ years of experience or a Bachelor's degree with 8+ years of experience in a relevant field such as Life Sciences, Biostatistics, Computer Science, or a related discipline
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 and diverse clinical trials from study initiation to completion and associated regulatory submission and inspection preparation
Oncology experience required
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 standards
Minimum of 3 days a week of onsite presence (or more as business needs require) in either Jersey City (NJ) or Millbrae (CA) offices

Responsibilities

Provide 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 plan, coordinate, and deliver 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 serve as a primary point of contact for internal and external study team members
Provide strong quality and project oversight over third party vendor responsible for data management deliverables
Take a leadership role to gather content and integration requirements for EDC and closely collaborate with partners supporting other data collection systems (eCOA, External Data, RTSM). Enforce data standard conventions and quality expectations for clinical data per defined processes
Author, review/revise 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
Chair Data Review meetings with cross functional study team members to ensure on-going review of trial data currency, quality and completeness
Represent DM on cross-functional project teams & submission teams
Lead or support the Health Authority inspections and audits
Provide 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, manage data currency throughout the trial, and perform overall monitoring DM deliverables according to the Service Level Agreement (SLA)
Lead/provide the relevant support to set up, validate the standard eCRF library

Skills

Key technologies and capabilities for this role

Clinical Data ManagementEDCeCOAExternal Data IntegrationVendor OversightData CollectionClinical Trial DataProject Management

Questions & Answers

Common questions about this position

What is the work arrangement or location policy for this role?

The role requires a minimum of 3 days a week of onsite presence (or more as business needs require) in either the Jersey City (NJ) or Millbrae (CA) offices.

What are the key skills or experience required for this position?

Candidates need expertise in clinical data management, strong collaboration skills, and a detail-oriented approach, with experience leading end-to-end data management activities for complex clinical projects.

What does the company culture emphasize for this role?

The culture emphasizes collaboration, high-performance delivery, operational excellence, and supporting significant team growth.

What salary or compensation is offered for this position?

This information is not specified in the job description.

What makes a strong candidate for this Senior Manager role?

A strong candidate is a driven, detail-focused expert in clinical data management with strong collaboration skills, experience leading complex projects, and the ability to provide oversight to vendors and junior staff.

Eikon Therapeutics

Biotech startup developing innovative medicines

About Eikon Therapeutics

Eikon Therapeutics focuses on discovering and developing new medicines in the pharmaceutical industry. The company employs advanced technologies to study biological systems, aiming to identify new drug targets by examining the dynamic aspects of biology rather than just static chemical processes. Their team consists of diverse professionals, including data scientists, chemists, and engineers, which allows them to combine science and engineering to create new therapies that aim to improve and extend life. A key feature of Eikon's approach is their proprietary single-molecule tracking (SMT) platform, which enables rapid visualization of protein movements in living cells. This technology, along with artificial intelligence and automation, allows for precise inventorying of molecular interactions. Eikon Therapeutics targets patients with serious diseases who need effective treatments, generating revenue through the development and commercialization of their therapies.

Hayward, CaliforniaHeadquarters

2019Year Founded

$750.8MTotal Funding

SERIES_CCompany Stage

AI & Machine Learning, BiotechnologyIndustries

201-500Employees

Benefits

401(k) Company Match

Medical (premiums covered by Eikon at 95%)

Dental Insurance

Vision Insurance

Mental Health Support

Unlimited Paid Time Off

Paid Holidays

Life Insurance

Enhanced Parental Leave

Daily subsidized lunch program

Risks

Competition from biotech unicorns like Abogen Biosciences is increasing.

Integrating new clinical-stage assets may delay drug development timelines.

Reliance on SMT technology risks obsolescence from emerging molecular biology technologies.

Differentiation

Eikon uses proprietary single-molecule tracking for real-time protein movement analysis.

The company integrates AI and automation for large-scale molecular interaction studies.

Eikon's diverse team combines expertise in science, engineering, and technology.

Upsides

Growing interest in SMT technology boosts Eikon's drug discovery potential.

Partnerships with AI firms enhance Eikon's drug candidate identification.

Rising demand for precision medicine aligns with Eikon's focus on dynamic biology.

Land your dream remote job 3x faster with AI

Try Jobo Free