Summit Therapeutics

Summit Therapeutics

Associate Director, Clinical Data Management

Palo Alto, CA · Director

Sponsorship not specifiedDetected 14 days ago
GCPData ScienceComplianceProject ManagementClinical TrialsFDA RegulatoryPharmacovigilanceResearchLeadershipCommunicationCollaborationBiostatistics

Stay score

odds of building a lasting career here

37Risky
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70

Thin sponsorship signal and lottery-bound. A low-probability bet with your clock running. Prioritize cap-exempt roles and proven entry-level sponsors first.

Lottery odds assume a STEM candidate.

Personalize to your clock →

Employer immigration record

from this employer's Department of Labor filings

Files H-1B transfers

4 transfer filings in the last year, covering 4 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.

Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.

Community outcomes

No reports yet — be the first to help the next applicant.

About the role

  • We are looking for an experienced Associate Director, Clinical Data Management that will contribute to and support the company's research and development efforts to create high value therapeutics to address unmet medical needs.
  • The Associate Director, Clinical Data Management independently leads the data management components of a clinical trial ranging from small early phase to large global and late phase programs.
  • This role will direct the planning, implementation and overall direction of executing/achieving clinical trial data management activities including CRF/eCRF design, database development, validation programming, data review, discrepancy management, and database lock.

Responsibilities

  • Provide expertise and contribute to the strategy and development of the Clinical Data Management Portfolios to ensure data quality in support of clinical study data milestones and deliverables
  • Lead and support establishment of systems and processes to help ensure clinical data security, integrity, and long-term goals of the business function, in alignment with company priorities
  • Leads the data management of overall drug development process with early and late phase clinical trials in large or complex development program(s)
  • Provides technical expertise to develop and implement clinical data standards, data management plans, data transfer agreements, and data flow processes to ensure timely and quality data delivery for analysis purpose
  • Leads, designs and/or oversees eCRF design, eCRF specifications, eCRF completion guidelines, annotated CRFs, User Acceptance Testing, query logic, edit checks, data query resolution, SAE reconciliation between clinical and pharmacovigilance databases, vendor data reconciliation & cleaning, data migration and database closeout for clinical trials
  • Supports cross functional teams and studies to handle data management questions, troubleshoot, help resolve issues and mitigate risks.
  • Works with the Director of Clinical Data Science (CDS) to enhance efficiency, optimize costs, and drive excellence
  • Leads clinical data management activities during regulatory audits, ensuring compliance with industry standards and regulations, and providing expert input throughout the audit process
  • Works with the Head of Statistical Programming & CDS to manage departmental budget and execute resource planning across multiple projects
  • Accommodate ad hoc data requests between clinical team members, scientists, and vendors to support data cleaning, data entry requirements and exploratory data review if needed

Nice to have

  • Summit's core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people.
  • Summit's team is inspired to touch and help change lives through Summit's clinical studies in the field of oncology.
  • Summit has multiple global Phase 3 clinical studies, including:
  • Non-small Cell Lung Cancer (NSCLC)
  • Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
  • Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.
  • Colorectal Cancer (CRC)
  • Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Skills

  • Bachelor's degree in Life Sciences, Computer Science, or relevant field of study; or equivalent practical experience
  • Excellent interpersonal, communication, and leadership skills
  • Consistent, detail oriented, communicative, dedicated to do a job well done
  • CRO and vendor oversight experience preferred
  • Strong knowledge of clinic

Company info

  • Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.
Apply directly at Summit Therapeutics →Create a free account for alerts like thisView Summit Therapeutics immigration profile

This listing is sourced directly from Summit Therapeutics's careers page and normalized into a canonical job model.