Associate Director, Data Management

1 month ago

waltham, United States Upstream Bio Full time

Position Summary:

This Associate Director, Data Management the clinical data management activities carried out by CROs and vendors in clinical programs. Collaborating closely with cross-functional teams, the role assumes a leadership position in end-to-end data acquisition planning and implementation. Additionally, it involves vigilant monitoring of risks and issues related to clinical data quality, as well as the provision of effective risk mitigations and solutions to address issues. The ideal candidate will possess up-to-date knowledge, proficient hands-on skills, and extensive experience in clinical data management.

Key Responsibilities:

  • Oversee clinical data management activities within clinical programs and exercise vendor oversight of clinical data deliverables, ensuring both quality and adherence to timelines.
  • Provide leadership in clinical data management aspects, including but not limited to CRF design, validation and programming of clinical database, management of data discrepancy, data extracts, and overseeing database locking and archiving.
  • Identify and evaluate impact of data quality issues through examination of the clinical database, vendor database, and Central Monitoring. Collaborate closely with cross functional teams to pinpoint and implement solutions, demonstrating leadership and oversight throughout the resolution process.
  • Collaborate seamlessly with colleagues and departments, such as statistics and statistical programming, pharmacovigilance, clinical operations, regulatory affairs, medical directors, and other functions supporting clinical programs.
  • 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. Learn more about us at upstreambio.com.

  • Associate Director, Data Management

    2 months ago

    Waltham, United States Upstream Bio Full time

    Position Summary: This Associate Director, Data Management the clinical data management activities carried out by CROs and vendors in clinical programs. Collaborating closely with cross-functional teams, the role assumes a leadership position in end-to-end data acquisition planning and implementation. Additionally, it involves vigilant monitoring of risks...

  • Associate Director, Data Management

    2 months ago

    waltham, United States Upstream Bio Full time

    Position Summary: This Associate Director, Data Management the clinical data management activities carried out by CROs and vendors in clinical programs. Collaborating closely with cross-functional teams, the role assumes a leadership position in end-to-end data acquisition planning and implementation. Additionally, it involves vigilant monitoring of risks...

  • Associate Director, Data Management

    2 months ago

    Waltham, United States Upstream Bio Full time

    Position Summary: This Associate Director, Data Management the clinical data management activities carried out by CROs and vendors in clinical programs. Collaborating closely with cross-functional teams, the role assumes a leadership position in end-to-end data acquisition planning and implementation. Additionally, it involves vigilant monitoring of risks...

  • Associate Director, Clinical Data

    1 week ago

    Waltham, United States Clinical Dynamix Full time

    ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data management strategy for the organization. The Associate Director, Clinical Data Management is responsible for overseeing the start-up and execution of multiple,...

  • Associate Director, Clinical Data

    2 days ago

    Waltham, United States Clinical Dynamix Full time

    ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data management strategy for the organization. The Associate Director, Clinical Data Management is responsible for overseeing the start-up and execution of multiple, complex...

  • Director, Data Management

    5 days ago

    Waltham, United States Upstream Bio Full time

    Position Summary: The Director of Data Management will lead end-to-end data acquisition planning and implementation. The Director will lead a small team of professionals, overseeing the data management activities carried out by CROs and vendors in clinical programs. Collaborating closely with cross-functional teams, the Director will vigilantly monitor risks...

  • Director, Data Management

    6 days ago

    Waltham, United States Upstream Bio Full time

    Position Summary: The Director of Data Management will lead end-to-end data acquisition planning and implementation. The Director will lead a small team of professionals, overseeing the data management activities carried out by CROs and vendors in clinical programs. Collaborating closely with cross-functional teams, the Director will vigilantly monitor risks...

  • Director, Data Management

    2 days ago

    Waltham, United States Upstream Bio Full time

    Position Summary:The Director of Data Management will lead end-to-end data acquisition planning and implementation. The Director will lead a small team of professionals, overseeing the data management activities carried out by CROs and vendors in clinical programs. Collaborating closely with cross-functional teams, the Director will vigilantly monitor risks...

  • Director, Data Management

    2 days ago

    Waltham, United States Upstream Bio Full time

    Position Summary:The Director of Data Management will lead end-to-end data acquisition planning and implementation. The Director will lead a small team of professionals, overseeing the data management activities carried out by CROs and vendors in clinical programs. Collaborating closely with cross-functional teams, the Director will vigilantly monitor risks...

  • Clinical Data Management Director

    4 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...

  • Associate Director, Data Management

    2 weeks ago

    Waltham, MA, United States Upstream Bio Full time

    Position Summary:This Associate Director, Data Management the clinical data management activities carried out by CROs and vendors in clinical programs. Collaborating closely with cross-functional teams, the role assumes a leadership position in end-to-end data acquisition planning and implementation. Additionally, it involves vigilant monitoring of risks and...

  • Associate Director, Data Analytics Engineering

    4 days ago

    Waltham, United States AstraZeneca GmbH Full time

    Associate Director, Data Analytics EngineeringGaithersburg, MD or Waltham, MAIntroduction to role:As a data analytics engineer you will be responsible for streamlining our usage of oncology real world and clinical data through the development of processes and tools that enable our data science teams to drive innovation. You will join a cross-functional team...

  • Upstream Bio | Director, Data Management | waltham, ma

    5 days ago

    waltham, United States Upstream Bio Full time

    Position Summary: The Director of Data Management will lead end-to-end data acquisition planning and implementation. The Director will lead a small team of professionals, overseeing the data management activities carried out by CROs and vendors in clinical programs. Collaborating closely with cross-functional teams, the Director will vigilantly monitor risks...

  • Upstream Bio | Director, Data Management | waltham, ma

    1 day ago

    waltham, United States Upstream Bio Full time

    Position Summary:The Director of Data Management will lead end-to-end data acquisition planning and implementation. The Director will lead a small team of professionals, overseeing the data management activities carried out by CROs and vendors in clinical programs. Collaborating closely with cross-functional teams, the Director will vigilantly monitor risks...

  • Senior Data Engineer

    2 months ago

    Waltham, United States Senior Data Engineer Full time

    Scipher Medicine is a precision immunology company that uses AI and network science to match patients with the most effective therapies. Its flagship product, PrismRA, is a blood-based test predicting whether a patient with RA will likely respond to anti-TNF therapy. Scipher Medicine is also developing the Spectra platform, which can be used to discover and...

  • Senior Data Engineer

    4 weeks ago

    Waltham, Massachusetts, United States Senior Data Engineer Full time

    We are seeking a skilled Senior Data Engineer to join our team at Scipher Medicine, a precision immunology company that utilizes AI and network science to match patients with the most effective therapies. Our flagship product, PrismRA, is a blood-based test predicting whether a patient with RA will likely respond to anti-TNF therapy. We are also developing...

  • Associate Director, Annual Giving

    2 days ago

    Waltham, United States EPIP Full time

    Bentley University is searching for a dynamic individual to join our Annual Giving team as an Associate Director of Annual Giving. This position will be responsible for the solicitation, development, and execution of personal solicitations and fundraising strategies to targeted affinity communities, such as athletics and young alumni, to help achieve dollar...

  • Associate Director IT Validation Lead

    4 weeks ago

    Waltham, Massachusetts, United States Dyne Therapeutics Inc Full time

    Job Title: Associate Director IT Validation LeadDyne Therapeutics Inc is seeking an experienced Associate Director IT Validation Lead to lead the IT validation efforts ensuring that all IT systems meet regulatory and compliance requirements for both internal and external stakeholders-especially within GXP environments.This role focuses on the development,...

  • Associate Director, Information Technology

    3 weeks ago

    waltham, United States Ventus Therapeutics Full time

    About us:Ventus Therapeutics is a clinical-stage biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets in immunology, inflammation, and neurology. Our proprietary drug discovery platform, ReSOLVE, gives us the ability to discover and develop...

  • Associate Director, Information Technology

    3 weeks ago

    Waltham, United States Ventus Therapeutics Full time

    About us:Ventus Therapeutics is a clinical-stage biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets in immunology, inflammation, and neurology. Our proprietary drug discovery platform, ReSOLVE, gives us the ability to discover and develop...