[Hiring] Lead Clinical Data Manager @Orca Bio

Role Description

The Lead Clinical Data Manager will be responsible for all aspects of clinical trial data management from study start up through database lock and study close. This includes:

• EDC build and user acceptance testing (UAT)
• Study data cleaning and reconciliation
• Query issue and resolution
• Database locks

They will ensure optimized data collection, flow and access across EDC and non-EDC data sources. They are also responsible for accuracy, consistency, completeness and CDISC compliance of all clinical databases. The role will operate as a key member of the Clinical Operations team.

Responsibilities

• Develop and maintain all data management documentation, including case report forms, data management plans, edit check specifications, data review plans and data transfer agreements.
• Design case report forms (CRFs) for electronic data capture (EDC) systems for data collection.
• Perform data entry and cleaning activities, including discrepancy management and query resolution.
• Conduct data validation checks and implement quality control measures to ensure accuracy and completeness.
• Collaborate with study team members to resolve data-related issues and discrepancies.
• Generate and review data listings, summaries and reports for data review.
• Serve as a primary or backup resource for issues about data management.
• Ensure compliance with guidelines, Good Clinical Practice (GCP), CDISC standards and other relevant regulations.
• Contribute to the development and validation of data management software tools.

Qualifications

• BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics or equivalent industry experience.
• 5-7+ years of data management experience in the pharmaceutical or biotechnology industries, preferably in smaller biotech sponsor environment.
• Strong expertise in project/program management including stakeholder management.
• Knowledge of industry standards (CDISC, SDTM, CDASH).
• In-depth understanding of Data Management regulatory guidelines: ICH, GCDMP, 21CFR Part 11.
• Proven ability to preemptively identify data and system issues and mitigate risks to data quality.
• Knowledge and experience with development, validation, execution, maintenance, documentation, and archival of clinical data.
• Experience in development and implementation of Clinical data management standards and procedures.
• Experience with web-based EDC, clinical data management systems and medical coding dictionaries such as MedDRA and WHO Drug.
• Prior experience with Zelta by Merative (formerly IBM) CDM platform preferred.

Requirements

• The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law.
• For remote-based positions, this range may vary based on your local market.
• Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits.
• Other perks include subsidized daily lunches and snacks at our on-site locations.

Company Description

We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.

• We live by our core values of passion, courage, and integrity.
• Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
• We innovate on a path that hasn’t been paved.
• We embrace an entrepreneurial spirit and take calculated risks to achieve our mission.
• We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
• We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.