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Clinical Trial Manager

Company: Hummingbird Bioscience
Location: Houston
Posted on: January 16, 2022

Job Description:

Clinical Trial Manager - Hummingbird Bioscience Inc.
(Full-time position - Texas-based, with preference in Houston)

Opportunity to work at the cutting edge of drug development

Hummingbird Bioscience is an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets to improve treatment outcomes. We harness the latest advances in systems biology and data science to better understand and solve the underlying causes of disease and guide development of our therapeutics.

Enabled by our proprietary Rational Antibody Discovery platform, we discover antibodies against optimal yet elusive epitopes on important targets that have not been successfully drugged, unlocking novel mechanisms of action. We are advancing a rich pipeline of first- and best-in-class precision therapies in oncology and autoimmunity, in collaboration with global partners in academia and industry.

Our highly experienced teams in the US and Singapore span antibody discovery, pharmacology, production, and clinical development. Together we aim to accelerate the journey of new drugs from concept to clinical care. For more information, please visit www.hummingbirdbioscience.com, and follow Hummingbird on LinkedIn and Twitter (@hummingbirdbio).

Join Hummingbird Bioscience on our journey as we transition from an early-stage drug discovery company to a global leader in drug development. We are looking for a Clinical Trial Manager who will work closely with the Chief Medical Officer, Head of Clinical Operations, Program Managers and selected Contract Research Organizations (CRO) to help drive the development and execution of -early-phase oncology clinical trials.

The Clinical Trial Manager supports the Head of Clinical Operations by taking responsibility for areas of clinical trial delivery. The Clinical Trial Manager works with the study team internally and externally with vendors such as CROs and other selected 3rd party vendors in feasibility, planning, initiation, maintenance and closeout of clinical projects according to GCP, ICH and Hummingbird Bioscience's Standard Operating Procedures (SOPs). Some travel to study sites may be required to assist with monitoring clinical studies.

The Clinical Trial Manager will be assigned activities by the Chief Medical Officer and the Head of Clinical Operations, including:
Responsible for the day-to-day progress of clinical trials and acting as the clinical pivot for the trials
Contributes to risk assessment and helps identify risk mitigation strategies
Supports feasibility assessment to select relevant investigators
Oversees and provides input to the development of study-specific documentation including but not limited to case report form (CRF), data management plan, monitoring plan, monitoring oversight plan, etc.
Reviews site-level informed consents and other patient-facing study start-up materials
Oversees setting up and maintenance of in-house study systems including but not limited to Clinical Trial Management System (CTMS) and Trial Master File (TMF)
Oversees engagement, contracting and management of required vendors for the study
Oversees and provides input to study drug and clinical supplies forecasting, drug accountability and drug reconciliation
Provides regular status reports to stakeholders as requested by the Head of Clinical Operations
Supports data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations and suspected non-compliance by sites
Escalates data flow and data quality issues to Head of Clinical Operations
Participates in UAT of eCRF build and validation documents
Leads data reviews with the clinical team to ensure accuracy, consistency and reliability
Reviews database metrics and implements an escalation process to achieve resolution of noted issues
Oversees the execution of the specific clinical study deliverables against planned timelines
Escalates issues related to timelines or budget to the Head of Clinical Operations
Supports accurate budget management and scope changes
Contributes to clinical project audit and inspection readiness throughout the study lifecycle
Supports internal and external inspection activities and contributes to CAPAs as required
Assists CRO in managing aspects of study closeout activities including but not limited to database lock, reconciliation of vendor contracts, study budgets, TMF and study drug accountability
May require 15% travel

Master's Degree required, advanced Clinical/Science Degree is preferred (e.g. PhD, MD, MSN, MPH, etc.).
5-10 years of clinical, technical/operational experience in planning, executing, reporting and publishing clinical studies within the biopharmaceutical industry; experience in clinical oncology is preferred, and experience in immuno-oncology is highly preferred.
Successful track record in interpreting, analyzing and presenting clinical data including aggregated data analyses; understanding of oncology clinical data preferred.
Thorough understanding of the drug development process from pre-IND through registration and post-registration required.
Detailed knowledge of Good Clinical Practice (GCP), ICH Guidelines, including E6 (R2) and current US FDA regulation
Excellent interpersonal skills with the ability to build strong relationships across internal and external partners.
Ability to work independently and with the flexibility to handle workflow in a fast-paced start-up environment.

To apply for this role, please apply on the careers page of our website with a maximum 2-page resume in PDF format, detailing your education and relevant experience, and a cover letter with your motivations for applying for this position. http://www.hummingbirdbioscience.com/en/careers/

Keywords: Hummingbird Bioscience, Houston , Clinical Trial Manager, Healthcare , Houston, Texas

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