Senior Clinical Data Manager

Role Summary

The Senior Clinical Data Manager (Sr. CDM) will be responsible for partnering with internal and external business functions and vendors throughout the life cycle of one or more clinical study(ies) in accordance with company SOPs, ICH/GCP, and all applicable local regulations. In this role, the Sr. CDM will assist in the design and implementation of Clinical Data management systems with vendors, ensuring completeness, correctness, and consistency to ensure deliverables are met, including data acquisition, quality data review and reporting in compliance with GCP quality expectations, with adherence to scope of work and service agreements. Candidates for this role must champion a culture of quality and continuous process improvement.

Location

Our work culture is a hybrid model with days in the New York City office and days working from home.   A remote working model may be considered for exceptional candidates.

Primary Responsibilities

• Serves as data lead for one or more clinical trials, assuming responsibility for all data management activities, including access levels and permissioning
• Proactively drive quality and efficiency to meet timelines and milestones for data management in close collaboration with cross functional study team(s)
• Conduct oversight of data management activities performed by the CROs and other 3rd party vendors (IRT, Safety, Lab, etc.) to meet Lexeo obligations and business objectives throughout study (ies) life cycle i.e. from protocol synopsis through database release and submission.
• Serve as a first point of contact for CRO DM partners to ensure established milestones and deliverables are met with the highest degree of quality
• Plan, perform and oversee development of specifications for eCRFs, edit checks, electronic data handling, manual review, and execution of User Acceptance Testing in collaboration with CROs and relevant Lexeo functional partners
• Review and provide input for all DM documentation - CRF Completion Guidelines, Data Management Plan, Data Transfer Specifications, etc.
• Work with the CRO to ensure all data cleaning tools are in place for EDC, IRT, SAE and all external data sources to ensure consistency, accuracy, and integrity of Clinical Data
• Manage end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other vendors to ensure deliverables are on time and of high quality.

Required Skills & Qualifications

• BA/BS degree or equivalent with a minimum of 6 years of relevant clinical trial data management lead experience within Biotech/Pharmaceutical industry and a degree in life sciences or equivalent. (Gene therapy experience a plus)
• In depth knowledge of industry leading eCRF tools and well versed in industry trends and emerging technologies supporting data collection.
• Proficient experience using commercial Clinical Data management systems and/or EDC products e.g. Medidata Rave.
• Knowledge of CDISC requirements; understanding of data collection requirements in oncology trials is required; understanding of SDTM requirements.
• Strong project management; exhibits expertise in metrics analysis and reporting methodologies.
• Extensive hands-on experience with Clinical Data management practices within industry sponsored clinical trials.
• Knowledge of dictionary structures (MedDRA, WHO Drug, etc.).
• Ability to develop strong and productive working relationships with internal and external key stakeholders.
• Knowledge of clinical research, FDA & ICH, GCP, GCDMP, related regulatory requirements.
• Proven direct experience with data management tasks as well as DM vendor oversight to meet aggressive timelines of high-quality data deliverables.
• Ability to handle multiple development programs simultaneously.
• Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills.
• Contribute to the growth and development of the DM team.
• Excellent written and verbal communication skills demonstrated by ability to present clear instruction/direction.
• Analytical and problem-solving capabilities
• Collaborative and collegial work style
• Attention to detail and follow-up

Anticipated Salary Range

Depending on qualifications and overall experience, base salary is likely to be $150,000 - $185,000 per year.

Lexeo Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment.

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