Clinical Data Management Director

3 weeks ago


Waltham, Massachusetts, United States Upstream Bio Full time
Position Summary:
As Associate Director, Data Management, you will oversee clinical data management activities within clinical programs, ensuring quality and adherence to timelines. This role assumes a leadership position in end-to-end data acquisition planning and implementation, collaborating closely with cross-functional teams to identify and evaluate the impact of data quality issues. You will provide leadership in clinical data management aspects, including CRF design, validation, and programming of clinical databases, management of data discrepancies, data extracts, and overseeing database locking and archiving.

Key Responsibilities:

Lead clinical data management activities, exercising vendor oversight of clinical data deliverables to ensure quality and adherence to timelines.

Provide leadership in clinical data management aspects, including CRF design, validation, and programming of clinical databases, management of data discrepancies, data extracts, and overseeing database locking and archiving.

Collaborate closely with cross-functional teams to identify and evaluate the impact of data quality issues, demonstrating leadership and oversight throughout the resolution process.

Cultivate and maintain productive working relationships with CROs and vendors to ensure the successful acquisition of data for clinical programs.


Qualifications:
Bachelor's degree preferred
8+ years of clinical data management experience
In-depth knowledge of clinical data management processes, systems, technologies, and industry advancements.

Demonstrated strategic thinking with direct experience in clinical data management functions such as CRO oversight, case report form development, database development, data validation, data reporting, database lock activities.

Proven track record of managing CROs and vendors, with experience overseeing a trial from start-up through database lock.
Strong hands-on skills in managing essential electronic data collection platforms, including EDC, clinical laboratory, eCOA, imaging, etc. Experience with data visualization tools is a plus.
A team player with a balance of independent and collaborative critical thinking skills. Possesses a forward-thinking mindset, capable of managing multiple projects, demonstrated ability of identifying and resolving issues.
Excellent verbal and written communication skills, fostering open and effective dialogue throughout the company.

About Upstream Bio:
Upstream Bio is a public company based in Waltham, MA. We are developing verekitug, the only known antagonist currently in development that targets the receptor for Thymic Stromal Lymphopoietin (TSLP). We have advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) and plan to initiate development in chronic obstructive pulmonary disease (COPD). Our experienced team is committed to maximizing verekitug's unique attributes to address the substantial unmet needs for patients underserved by today's standard of care.

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