Senior Clinical Data Manager

Senior Clinical Data Manager

Reporting to : Senior Director, Clinical Data Management

Do you have the passion and commitment to join a group whose mission is to develop treatments that have a clear and profound impact on patients suffering from rare diseases?

Does it excite you to be a part of a patient-focused company developing potential new treatments that could dramatically improve the lives of patients with limited to no current treatment options?

If yes, we encourage you to share with us your aspirations and career goals.

X4 is focused on restoring healthy immune system function by developing novel therapeutics to treat chronic neutropenic disorders, including WHIM syndrome, a rare primary immunodeficiency.

We are advancing a novel, late-stage clinical candidate, mavorixafor, that we believe has the potential to become a new standard of care for patients with these disorders.

We know that developing innovative, new medicines is challenging, and we invite new colleagues who share our values and commitment to join us in achieving our mission.

This opportunity will

• Align with your values and grit, and passion for innovative science.
• Leverage your deep knowledge of clinical data management to support our innovative science and allow you to have a major impact on our mission to support our patients.
• Offer a collegial environment with a team-based approach, where our mission drives our values, behaviors, and creativity.

Accountabilities and Responsibilities :

• Drive and lead the development of all eCRFs and EDC design.
• Plan, develop and implement data specifications, data entry guidelines, CRF completion guidelines, and related operational manuals / guidelines.
• Develop and execute data validation guidelines and measures to ensure accurate data gathering from clinical studies.
• Review and provide expertise on all eCRF changes and respond accordingly to make resulting database changes.
• Organize and direct the initial stage of the studies, and review and sign off on various items such as eCRF, data validation, data review guidelines, and data management plans.
• Oversee and build strong sustainable relationships with multiple global CROs / vendors along with managing the process and coordination of each.
• Accountable for ensuring all data quality and timeliness of CDM deliverables are met and aligned with the business goals;

coordinate with all functions to drive data cleaning.

• Responsible for managing the clinical trial data queries along with the planning and execution of medical coding and SAE reconciliation.
• Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the trial master file (TMF).
• Partner with cross functional key stake holders to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting;

serve as an internal expert on data management with vendors.

Reputation for data integrity and compliance.

Requirements : Proven Experience, Skills, and Education :

• Bachelor’s degree required within a scientific discipline; advanced degree is a plus.
• 8+ years of experience within biotech / biopharma and / or CRO organizations.
• Extensive knowledge and experience in clinical data management.
• Direct experience with different Data Management systems and technologies, Clinical Data Management Systems and CDISC data standards.
• Extensive knowledge reviewing study planning documents such as Edit Check Specs, UAT scripts, and Data Management Plans.
• Direct experience building Clinical Data Management Systems.
• Comprehensive understanding of database and dictionary structures (e.g., MedDRA, WHO DRUG).
• Deep understanding of drug development, study conduct processes, GCP and regulations related clinical data management as well as ICH guidelines, FDA / EU regulations.
• Demonstrated experience in managing multiple CROs / vendors.
• Exceptional communication and cross-functional collaboration skills

This position is based in Boston, MA, and offers a flexible hybrid work model with a minimum of 2 days / week in the office.

We encourage you to learn more about X4 Pharmaceuticals. Click on the links below!

X4 Pharmaceuticals is an Equal Opportunity, and Affirmative Action Employer committed to a culturally diverse workforce.

All qualified candidates will receive consideration without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender identity or expression, sexual orientation, disability, veteran status, violence victim status or any other characteristic protected by law.

Please note that effective January 1, 2022, as a condition of employment at X4 Pharmaceuticals, all employees and new employees must have received their complete doses of the COVID-19 vaccine and one booster unless they have been granted an exemption by X4.

LI-Hybrid