Associate Director, Clinical Data Management
About The Position
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. 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.
Requirements
- 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.
- Extensive experience in clinical data management, including data collection, database design, and quality assurance.
- In-depth understanding of the biotechnology or pharmaceutical industry and its data management practices, particularly within clinical research.
- Proficiency in relevant data management tools and software, including electronic data capture (EDC) systems and data coding standards.
- Thorough knowledge of regulatory guidelines related to clinical data management and data integrity.
- Demonstrated leadership skills and experience in guiding and mentoring data management teams.
- Strong analytical and problem-solving skills, with the ability to address data-related challenges effectively.
- Excellent interpersonal and communication skills to collaborate seamlessly with cross-functional teams and external partners.
Nice To Haves
- Oncology experience preferred.
- Veeva EDC experience is a plus.
Responsibilities
- Provide strategic direction and leadership for the clinical data management team, ensuring alignment with company objectives and industry best practices.
- Collaborate with cross-functional teams to develop and implement data collection strategies, tools, and systems that meet study goals and regulatory requirements.
- Oversee data quality control processes, including validation, discrepancy management, and reconciliation, to ensure the accuracy and completeness of collected data.
- Lead the design and maintenance of electronic data capture (EDC) systems or databases, ensuring their efficiency and capability to capture essential data elements.
- Ensure adherence to data standards, industry best practices, and relevant guidelines throughout the data management lifecycle.
- Work closely with cross-functional teams, including biostatisticians, clinical researchers, and regulatory experts, to facilitate seamless data integration and analysis.
- Ensure that all data management activities are conducted in full compliance with applicable regulatory standards and guidelines.
- Maintain accurate and comprehensive documentation of data management processes, decisions, and workflows.
- Identify and address complex data management challenges proactively, proposing effective solutions to enhance data quality and operational efficiency.
- Mentor and develop data management team members, fostering their professional growth and ensuring a high level of performance.
Benefits
- Bonus and equity compensation
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Manager
