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Lead Clinical Data Manager

May 26, 2026

More than one million people in the United States today are fighting blood cancer. While a traditional <a href="https://www.mayoclinic.org/tests-procedures/allogeneic-stem-cell-transplant/pyc-20384863" class="postings-link">allogeneic stem cell transplant</a> has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. Summary: 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 the EDC build and user acceptance testing (UAT), study data cleaning and reconciliation, query issue and resolution, and 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<ul> <li>Develop and maintain all data management documentation, including case report forms, data management plans, edit check specifications, data review plans and data transfer agreements.</li> <li>Design case report forms (CRFs) for electronic data capture (EDC) systems for data collection.</li> <li>Perform data entry and cleaning activities, including discrepancy management and query resolution.</li> <li>Conduct data validation checks and implement quality control measures to ensure accuracy and completeness.</li> <li>Collaborate with study team members to resolve data-related issues and discrepancies.</li> <li>Generate and review data listings, summaries and reports for data review</li> <li>Serve as a primary or backup resource for issues about data management.</li> <li>Ensure compliance with guidelines, Good Clinical Practice (GCP), CDISC standards and other relevant regulations.</li> <li>Contribute to the development and validation of data management software tools. </li> </ul> Qualifications<ul> <li>BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics or equivalent industry experience.</li> <li>5-7+ years of data management experience in the pharmaceutical or biotechnology industries, preferably in smaller biotech sponsor environment.</li> <li>Strong expertise in project/program management including stakeholder management.</li> <li>Knowledge of industry standards (CDISC, SDTM, CDASH).</li> <li>In-depth understanding of Data Management regulatory guidelines: ICH, GCDMP, 21CFR Part 11.</li> <li>Proven ability to preemptively identify data and system issues and mitigate risks to data quality.</li> <li>Knowledge and experience with development, validation, execution, maintenance, documentation, and archival of clinical data.</li> <li>Experience in development and implementation of Clinical data management standards and procedures.</li> <li>Experience with web-based EDC, clinical data management systems and medical coding dictionaries such as MedDRA and WHO Drug.</li> <li>Prior experience with Zelta by Merative (formerly IBM) CDM platform preferred.</li> </ul> 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. Who we are 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 aren’t afraid to ask “why not” and challenge the status quo. 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. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.

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Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

Many people want to work remotely because of the flexibility it allows. You can work anywhere and at any time of the day...

4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

5. HOW DO YOU PROCESS INFORMATION?

Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

8. HOW TO PRIORITIZE WORK?

The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

Just as communication is essential when working remotely, so is organization. Because you won't have those opportunities in the elevator or a casual conversation in the lunchroom, you should take advantage of the little time you have in a video or phone conference...

10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...