Associate Director, Clinical Data Management

Eikon Therapeutics; Millbrae (CA); Hybrid; USD 178,000 - 215,000; Full time

Benefits offered by this job

401k plan with company matching

Medical, dental, and vision insurance

Mental health and wellness benefits

Paid time off and holidays

Job summary

Eikon Therapeutics, a pioneer in real-time cellular data, seeks an Associate Director of Clinical Data Management. The role drives strategic leadership and oversees data collection, EDC system design, and QA across studies in a hybrid work model with NJ or CA offices.

You will guide cross-functional teams, ensure regulatory compliance, and advance data integrity from collection through analysis, leveraging cutting-edge tools and industry best practices.

Qualifications

• Post graduate degree with 8+ years of relevant experience or a Bachelor's degree with 10+ years.
• Extensive experience in clinical data management, including data collection, database design, and quality assurance.
• In-depth understanding of biotech/pharma industry data management practices and regulatory guidelines.

Responsibilities

• Provide strategic direction and leadership for the clinical data management team.
• Develop and implement data collection strategies, tools, and systems for study goals and regulatory requirements.
• Oversee data quality control processes, including validation, discrepancy management, and reconciliation.
• Lead the design and maintenance of electronic data capture (EDC) systems or databases.
• Ensure adherence to data standards and regulatory guidelines throughout the lifecycle.
• Collaborate with biostatisticians, clinicians, and regulatory experts to enable data integration and analysis.
• Maintain documentation of processes, decisions, and workflows.
• Mentor and develop team members to sustain high performance.

Skills

Leadership

Data management

Regulatory knowledge

EDC systems

Data standards

Cross-functional collaboration

Analytical skills

Problem solving

Oncology experience

Veeva EDC

Education

Postgraduate degree

Bachelor's degree

Tools

Veeva EDC

Job description

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 seeking a highly skilled and experienced Associate Director, Clinical Data Management, to provide strategic leadership and operational oversight for our data management activities. As an Associate Director, you will play a pivotal role in driving the planning, execution, and quality assurance of clinical data management processes, ensuring the integrity, accuracy, and compliance of data throughout the research lifecycle. This role requires a minimum of 3 days per week onsite (or more, as business needs require) in either our Jersey City (NJ), or Millbrae (CA) offices.

About You

You have extensive expertise in clinical data management, including data collection, database design, and quality assurance, along with a deep understanding of industry-specific data management practices. You also have technical proficiency in data management tools and software, comprehensive knowledge of regulatory guidelines, strong leadership skills, analytical acumen, and excellent interpersonal and communication abilities to collaborate effectively with cross-functional teams and partners.

What You’ll Do

• Leadership and Strategy: Provide strategic direction and leadership for the clinical data management team, ensuring alignment with company objectives and industry best practices.
• Data Management Planning: Collaborate with cross-functional teams to develop and implement data collection strategies, tools, and systems that meet study goals and regulatory requirements.
• Quality Control: Oversee data quality control processes, including validation, discrepancy management, and reconciliation, to ensure the accuracy and completeness of collected data.
• Database Management: Lead the design and maintenance of electronic data capture (EDC) systems or databases, ensuring their efficiency and capability to capture essential data elements.
• Data Standards and Compliance: Ensure adherence to data standards, industry best practices, and relevant guidelines throughout the data management lifecycle.
• Team Collaboration: Work closely with cross-functional teams, including biostatisticians, clinical researchers, and regulatory experts, to facilitate seamless data integration and analysis.
• Regulatory Adherence: Ensure that all data management activities are conducted in full compliance with applicable regulatory standards and guidelines.
• Documentation: Maintain accurate and comprehensive documentation of data management processes, decisions, and workflows.
• Problem-Solving: Identify and address complex data management challenges proactively, proposing effective solutions to enhance data quality and operational efficiency.
• Team Development: Mentor and develop data management team members, fostering their professional growth and ensuring a high level of performance.

Qualifications

• Post Graduate degree with 8+ years of relevant experience or a Bachelor’s degree with 10+ years of relevant experience in a field such as Life Sciences, Biostatistics, Computer Science, or a related discipline.
• Data Management Expertise: Extensive experience in clinical data management, including data collection, database design, and quality assurance.
• Industry Knowledge: In-depth understanding of the biotechnology or pharmaceutical industry and its data management practices, particularly within clinical research.
• Technical Proficiency: Proficiency in relevant data management tools and software, including electronic data capture (EDC) systems and data coding standards.
• Regulatory Acumen: Thorough knowledge of regulatory guidelines related to clinical data management and data integrity.
• Leadership Experience: Demonstrated leadership skills and experience in guiding and mentoring data management teams.
• Analytical Skills: Strong analytical and problem-solving skills, with the ability to address data-related challenges effectively.
• Collaborative Approach: Excellent interpersonal and communication skills to collaborate seamlessly with cross-functional teams and external partners.
• Oncology experience preferred.
• Veeva EDC experience is a plus.

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 $178,000 to $215,250 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.