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Over one million people in the world today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many patients, the transplant itself can prove fatal or lead to serious conditions, such as graft versus host disease.
Orca Bio's investigational, high-precision cell therapies are designed to replace a patient's compromised blood and immune system with a healthy one, while dramatically lowering the risk of developing life-threatening or debilitating transplant-related side-effects. The first application of Orca Bio’s platform is in blood cancer where the unmet need is most acute; with a robust pipeline of promising cell therapies, we plan to extend into autoimmune diseases and genetic blood disorders as well.
The AD/Director of Clinical Data Management will be responsible for all aspects of clinical trial data management from study start up through database lock and study close. This includes the EDC build and user acceptance testing (UAT), study data cleaning and reconciliation, query issue and resolution, and database locks. They ensure optimized data collection, flow and access across EDC and non-EDC data sources. The AD/Director of Clinical Data Management is 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.
Oversee and direct clinical data management activities across multiple studies.
Serve as data management subject matter expert and provide technical expertise for clinical data systems.
Manage end-to-end data management activities, including design, build, launch, daily operation and close of Orca’s clinical trials database.
Provide leadership in gathering content and requirements for EDC; performs and organizes all aspects of the clinical database build and cross-functional User Acceptance Testing (UAT).
Enforce data standard conventions and quality expectations for clinical data per defined processes.
Provide direction, guidance, and quality oversight to team members, including consultants and vendors to achieve corporate goals and milestones.
Oversee the tracking of important study metrics on data entry, source data verification, query status, and data trends.
Author and review/revise DM related study plans including Data Quality Management Plan, Data Validation Plan, Data review plan, eCRF Completion Guidelines, and other study documents to ensure quality and standardization.
Develop and implement data structure standards based on CDASH/SDTM.
Direct activities to lock clinical databases: Develop timelines/milestones for data cleaning, identify and lead data review tasks.
Provide strategic input into the design of data flow across EDC and non-EDC data sources.
Manage development and periodic review of clinical data management specific SOPs.
Continuously test clinical data systems to identify functional issues. Define and execute mitigation strategies early to ensure a positive user experience.
Own clinical database quality control. Define data parsing strategies to identify anomalous data. Manage the implementation and execution of corrections.
Creatively define, develop, implement and enforce use of systems that simplify and improve clinical data capture and quality.
BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics or equivalent industry experience.
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 (IBM Clinical preferred), clinical data management systems and medical coding dictionaries such as MedDRA and WHO Drug.
A background in programming is preferred.
5 years of data management experience in the pharmaceutical or biotechnology industries.
Entrepreneurial and passionate; enjoys working in a fast-paced, collaborative environment.
Highly detail-oriented with special attention to quality and quality control.
Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize.
Excellent problem resolution and organizational skills; desire to improve upon established processes.
Strong interpersonal skills, including verbal and written communication, are essential.
Ability to work independently and as part of a team.
Flexibility in responding to change or business needs.
Who we are
We are scientists, engineers and business operators working with urgency to develop new therapies for patients faced with no or extremely limited options today.
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 patients who need them.
We strive to do things right. Excellence in our work means the potential to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate daily on a path that hasn’t been paved. This means we lean heavily on our entrepreneurial spirit and are comfortable taking calculated risks to achieve progress toward our mission. It means we aren’t afraid to ask “why not”, and encourage lively discourse around rethinking the status quo.
We work hard to preserve our start-up culture rooted in camaraderie and leadership by example - by everyone, regardless of title.
We’re proud to be an equal opportunity employer, and have seen how our differences - when celebrated and woven together - create stronger and more lasting solutions that better serve our team, our partners, and most importantly, our patients and the providers who treat them.
We invite you to join us and bring your unique perspective and experiences to our team.