Associate Manager, Clinical Data Management

CRISPR Therapeutics, Inc.; Boston (MA); Hybrid; USD 100.000 - 115.000; Vollzeit

Zusammenfassung

CRISPR Therapeutics, Inc. in Boston, MA is seeking an Associate Manager, Clinical Data Management to support data management across all stages of clinical drug development.

You will ensure data capture systems, processes, and documentation yield accurate, complete, and high-quality data, including data review, query management, and reconciliation. Collaborating with study teams and vendors, you will develop CDM documentation, oversee UAT, and contribute to SOPs and inspection readiness while

Qualifikationen

• Bachelor0s Degree in a health-related field.
• 4-6+ years of clinical data management experience at Sponsor, CRO, and/or Investigative site.
• Knowledge and experience with Microsoft applications including Word, MS Project, PowerPoint.
• Knowledge and experience with major EDC databases including Medidata Rave, Veeva, etc.
• Experience developing reports using J-Review, BOXI, and/or other CDM reporting tools, including data visualization software.
• Knowledge of CDASH/SDTM/CDISC standards.
• Experience working with central and specialty labs/vendors.
• Knowledge of medical terminology and medical coding dictionaries including MedDRA and WHODrug.
• Familiarity with GCP, ICH, and FDA requirements as applicable for Clinical Data Management.
• Able to manage multiple initiatives and shifting priorities within a small company environment.
• Strong analytical and problem-solving skills that meet or improve the status quo.
• Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment.
• Excellent written and oral communication skills.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

Aufgaben

• Plan, coordinate, and manage data management tasks and timelines.
• Collaborate with internal cross functional management to ensure all stakeholders7 needs are addressed.
• Lead the development of data management documentation including CRFs, CCGs, edit check specifications, SAE reconciliation plans, Coding plans, Data Management Plans, and third-party vendor data specifications; Coordinate related reviews with cross functional team(s).
• Ensure proper filing and documentation of clinical data management documents.
• Lead and participate in UAT of clinical data management systems.
• Lead and participate in clinical data review and data reconciliation.
• Prepare content and participate in study team meetings.
• Contribute to departmental SOP and process development/improvement and integration of technology.
• Support GCP inspection readiness.

Kenntnisse

Analytical skills

Communication

Multitasking

Team collaboration

GCP knowledge

Ausbildung

Bachelor7s Degree in a health-related field

Tools

Medidata Rave

Veeva

J-Review

BOXI

CDISC standards

CDASH/SDTM

Microsoft Word

Microsoft Project

PowerPoint

Jobbeschreibung

Job Description: Company Overview

Founded over a decade ago, CRISPR Therapeutics is a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY® (exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion‑dependent beta thalassemia. CRISPR Therapeutics is advancing a broad and diversified pipeline across hemoglobinopathies, cardiovascular, autoimmune, oncology, regenerative medicine and rare diseases. The Company continues to expand its leadership in gene editing through the development of SyNTase™ editing, a novel and proprietary gene‑editing platform designed to enable precise, efficient, and scalable gene correction. To accelerate and expand its impact, CRISPR Therapeutics has established strategic collaborations with leading biopharmaceutical partners, including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly‑owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California.

Position Summary

The Associate Manager, Clinical Data Management will support data management activities for CRISPR studies across all stages of clinical drug development. Working closely with clinical study teams and cross functional stakeholders, they will help ensure that data capture systems, processes, and documentation produce accurate, consistent, complete, and high‑quality clinical data. The role will include clinical data review, query management, and data reconciliation, with additional responsibilities spanning data management documentation, user acceptance testing, third‑party vendor data, and GCP inspection readiness.

Responsibilities

Plan, coordinate, and manage data management tasks and timelines. Collaborate with internal cross functional management to ensure all stakeholders’ needs are addressed. Lead the development of data management documentation including CRFs, CCGs, edit check specifications, SAE reconciliation plans, Coding plans, Data Management Plans, and third‑party vendor data specifications; Coordinate related reviews with cross functional team(s). Ensure proper filing and documentation of clinical data management documents. Lead and participate in UAT of clinical data management systems. Lead and participate in clinical data review and data reconciliation. Prepare content and participate in study team meetings. Contribute to departmental SOP and process development/improvement and integration of technology. Support GCP inspection readiness.

Minimum Qualifications

• Bachelor’s Degree in a health‑related field.
• 4‑6+ years of clinical data management experience at Sponsor, CRO, and/or Investigative site.
• Knowledge and experience with Microsoft applications including Word, MS Project, PowerPoint.
• Knowledge and experience with major EDC databases including Medidata Rave, Veeva, etc.
• Experience developing reports using J-Review, BOXI, and/or other CDM reporting tools, including data visualization software.
• Knowledge and experience with CDASH/SDTM/CDISC standards.
• Experience working with central and specialty labs/vendors.
• Knowledge of medical terminology and medical coding dictionaries including MedDRA and WHODrug.
• Familiarity with GCP, ICH, and FDA requirements as applicable for Clinical Data Management.
• Able to manage multiple initiatives and shifting priorities within a small company environment.
• Strong analytical and problem‑solving skills that meet or improve the status quo.
• Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment.
• Excellent written and oral communication skills.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

Preferred Qualifications

• Experience with global studies using an outsourced CRO model.
• Experience in early phase clinical drug development including first‑in‑human studies.
• Experience with drug development and management of data in rare genetic diseases, in vivo treatments, and/or CAR‑T cell therapies.

Competencies

• Collaborative – Openness, One Team Undaunted – Fearless, Can‑do attitude
• Results Orientation – Delivering progress toward our mission.
• Sense of urgency in solving problems.
• Entrepreneurial Spirit – Proactive.
• Ownership mindset.

Responsibilities

CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in‑person interactions. Our employees work at least three days on‑site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross‑functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on‑site. Associate Manager: Base pay range of $100,000 to $115,000+ bonus, equity and benefits The range provided is CRISPR Therapeutics’ reasonable estimate of the base compensation for this role. The actual amount will be based on job‑related and non‑discriminatory factors such as experience, training, skills, and abilities. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research‑stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize‑winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly‑owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy