Alterome Therapeutics, Inc.
Director, Clinical Data Management
Alterome Therapeutics, Inc., San Diego, California, United States, 92189
About Alterome:
Alterome Therapeutics, Inc. was formed in December 2021 and officially launched operations in January 2022. We are a precision oncology biotech developing alteration-specific therapeutics to address high-value and validated oncogenic drivers. The company is led by a team of experienced leaders with a history of developing marketed oncology small molecule drugs. Alterome recently secured $132 million in Series B funding.
Job Summary:
We are seeking a Director, Clinical Data Management to join our Oncology Clinical Development team. The Director, Clinical Data Management will contribute to the development, planning and execution of clinical studies and will ensure scientific integrity and interpretation of study data of the clinical program(s). In this position, you will have the opportunity to develop your leadership, technical and critical thinking skills as a part of a cross-functional team. The Director, Clinical Data Management will report to the head of biometrics under the Chief Medical Officer.
How You’ll Contribute to the Team:
The Director, Clinical Data Management will be responsible for daily data management tasks for all phases of clinical trials including CRO oversight and support other functional areas such as clinical operations, statistical programming, biostatistics, and medical monitor. The Director, Clinical Data Management will ensure the accuracy, consistency, completeness, and high quality of the clinical database. The role will be to work closely with cross-functional teams on the clinical development program, health authority submissions, presentations, and publications across internal and external stakeholders. Key Data Manager Responsibilities will include:
Lead clinical data management oversight of Alterome clinical trials including project management, CRO oversight, coordination of internal reviews, and approval of day-to-day data management deliverables.
Set up data management vendors as required, including review of RFPs, reviewing, and negotiating data management budgets and contracts.
Leads the development and review of all Clinical Data Management related documents including Data Management Plans, CRF design and CRF Completion Guidelines, edit check specifications, data transfer plan, etc.
Liaising with study management CRO and internal cross-functional teams to ensure adequate site training, timely initiation, and overall data integrity.
Provide direction and guidance to team members, including consultants and vendors, as well as other cross-functional groups to achieve study goals and milestones.
Oversee database design and post-production updates, ensuring that CROs, vendors, and internal staff meet the highest quality standards per the latest industry standard and regulatory authority requirements.
Responsible for sponsor user acceptance testing, including documenting findings and resolving with CRO.
Oversee data management activities including reconciliation between external data and EDC data, data flow metrics, database migration, medical coding and driving data snapshot/closeout activities.
Proactively identifies risks and executes risk mitigation strategies; Maintains timely communication with both upper management and cross-functional teams.
Oversees CRO/Vendor activities to ensure GCP compliance, quality expectations are met, and timelines are adhered to.
Contribute to program deliverable timeline creation and project re-forecasting.
Support data management activities for regulatory submissions.
Lead the development of CDM related Standard Operating Procedures (SOPs) and Work instructions.
Performs additional duties as assigned.
Required Qualifications:
Bachelor’s degree required with minimum of 6 years of hands-on data management/CDM experience in CRO, biotech or pharmaceutical industry.
Oncology experience is required; Early phase experience is preferred.
Experience leading clinical studies from study start up to database lock and managing multiple programs, and/or multiple studies within a program.
Strong vendor oversight experience.
Experience managing and collaborating with multiple external data providers such as central lab and central readers.
Experience working with eTMF systems and inspection readiness activities.
Understanding the principles of clinical research, ICH GCP (Good Clinical Practice), 21 CFR part 11, GCDMP (Good Clinical Data Management Practices) and related regulatory requirements.
Expertise with CDISC standards, including CDASH and SDTM; Working knowledge of SAS or SQL preferred.
Proficiency with major EDC tools (Medidata Rave EDC, Veeva EDC, etc.).
Proficient in Microsoft Word, PowerPoint, MS Project, Outlook and SharePoint.
Ability to use a combination of Electronic Data Capture (EDC) systems and/or other internal or commercial software tools and proven ability to learn and apply new software quickly as projects require.
Ability to work well in a team environment both as a leader and a contributor.
Excellent communication skills (written and oral) across all organizational levels.
Collaborative, respectful, agile and transparent work style.
Proven leadership experience and accomplishment in all aspects of conducting global clinical trials and execution of clinical programs.
Who are Alterome Employees?
Although we share varied backgrounds and come with expertise in different areas, we aim to inspire hope for those affected by cancer. Our vision unites us to develop unique therapies that transform the lives of cancer patients, one alteration at a time. Thus, we seek the best people to join this special movement and invest the resources they need to grow, develop, and accomplish our collective goals. We have a passion for what we do and truly enjoy working with each other. In fact, many of us have worked together in multiple companies and there is a genuine camaraderie amongst the group. We would love to bring new faces to the group, and that’s where you come in!
Alterome Offers:
We provide our employees with medical, dental, and vision coverage, life insurance, a 401k w/company matching, competitive compensation (including equity), paid holidays, flexible time off, home office set up, full-service gym on-site (with showers and towel service!), professional development opportunities, phenomenal company culture, and more! Our office is centrally located in San Diego, CA at the intersection of the 15 and 56 Freeways. This is a hybrid role with three days per week in the office required.
Salary Range:
$209,000 - $242,000/year based on skills and experience.
EEOC Statement:
Alterome Therapeutics, Inc. is an equal opportunity employer committed to building a diverse and inclusive organization. We measure each applicant, candidate, and employee based on their qualifications for the role, regardless of age, sex, religion, sexual orientation, gender identity, national origin, Veteran status, disability, and/or any other protected class characteristics. Furthermore, Alterome is committed to achieving all business objectives in compliance with all federal, state, and local laws.
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Alterome Therapeutics, Inc. was formed in December 2021 and officially launched operations in January 2022. We are a precision oncology biotech developing alteration-specific therapeutics to address high-value and validated oncogenic drivers. The company is led by a team of experienced leaders with a history of developing marketed oncology small molecule drugs. Alterome recently secured $132 million in Series B funding.
Job Summary:
We are seeking a Director, Clinical Data Management to join our Oncology Clinical Development team. The Director, Clinical Data Management will contribute to the development, planning and execution of clinical studies and will ensure scientific integrity and interpretation of study data of the clinical program(s). In this position, you will have the opportunity to develop your leadership, technical and critical thinking skills as a part of a cross-functional team. The Director, Clinical Data Management will report to the head of biometrics under the Chief Medical Officer.
How You’ll Contribute to the Team:
The Director, Clinical Data Management will be responsible for daily data management tasks for all phases of clinical trials including CRO oversight and support other functional areas such as clinical operations, statistical programming, biostatistics, and medical monitor. The Director, Clinical Data Management will ensure the accuracy, consistency, completeness, and high quality of the clinical database. The role will be to work closely with cross-functional teams on the clinical development program, health authority submissions, presentations, and publications across internal and external stakeholders. Key Data Manager Responsibilities will include:
Lead clinical data management oversight of Alterome clinical trials including project management, CRO oversight, coordination of internal reviews, and approval of day-to-day data management deliverables.
Set up data management vendors as required, including review of RFPs, reviewing, and negotiating data management budgets and contracts.
Leads the development and review of all Clinical Data Management related documents including Data Management Plans, CRF design and CRF Completion Guidelines, edit check specifications, data transfer plan, etc.
Liaising with study management CRO and internal cross-functional teams to ensure adequate site training, timely initiation, and overall data integrity.
Provide direction and guidance to team members, including consultants and vendors, as well as other cross-functional groups to achieve study goals and milestones.
Oversee database design and post-production updates, ensuring that CROs, vendors, and internal staff meet the highest quality standards per the latest industry standard and regulatory authority requirements.
Responsible for sponsor user acceptance testing, including documenting findings and resolving with CRO.
Oversee data management activities including reconciliation between external data and EDC data, data flow metrics, database migration, medical coding and driving data snapshot/closeout activities.
Proactively identifies risks and executes risk mitigation strategies; Maintains timely communication with both upper management and cross-functional teams.
Oversees CRO/Vendor activities to ensure GCP compliance, quality expectations are met, and timelines are adhered to.
Contribute to program deliverable timeline creation and project re-forecasting.
Support data management activities for regulatory submissions.
Lead the development of CDM related Standard Operating Procedures (SOPs) and Work instructions.
Performs additional duties as assigned.
Required Qualifications:
Bachelor’s degree required with minimum of 6 years of hands-on data management/CDM experience in CRO, biotech or pharmaceutical industry.
Oncology experience is required; Early phase experience is preferred.
Experience leading clinical studies from study start up to database lock and managing multiple programs, and/or multiple studies within a program.
Strong vendor oversight experience.
Experience managing and collaborating with multiple external data providers such as central lab and central readers.
Experience working with eTMF systems and inspection readiness activities.
Understanding the principles of clinical research, ICH GCP (Good Clinical Practice), 21 CFR part 11, GCDMP (Good Clinical Data Management Practices) and related regulatory requirements.
Expertise with CDISC standards, including CDASH and SDTM; Working knowledge of SAS or SQL preferred.
Proficiency with major EDC tools (Medidata Rave EDC, Veeva EDC, etc.).
Proficient in Microsoft Word, PowerPoint, MS Project, Outlook and SharePoint.
Ability to use a combination of Electronic Data Capture (EDC) systems and/or other internal or commercial software tools and proven ability to learn and apply new software quickly as projects require.
Ability to work well in a team environment both as a leader and a contributor.
Excellent communication skills (written and oral) across all organizational levels.
Collaborative, respectful, agile and transparent work style.
Proven leadership experience and accomplishment in all aspects of conducting global clinical trials and execution of clinical programs.
Who are Alterome Employees?
Although we share varied backgrounds and come with expertise in different areas, we aim to inspire hope for those affected by cancer. Our vision unites us to develop unique therapies that transform the lives of cancer patients, one alteration at a time. Thus, we seek the best people to join this special movement and invest the resources they need to grow, develop, and accomplish our collective goals. We have a passion for what we do and truly enjoy working with each other. In fact, many of us have worked together in multiple companies and there is a genuine camaraderie amongst the group. We would love to bring new faces to the group, and that’s where you come in!
Alterome Offers:
We provide our employees with medical, dental, and vision coverage, life insurance, a 401k w/company matching, competitive compensation (including equity), paid holidays, flexible time off, home office set up, full-service gym on-site (with showers and towel service!), professional development opportunities, phenomenal company culture, and more! Our office is centrally located in San Diego, CA at the intersection of the 15 and 56 Freeways. This is a hybrid role with three days per week in the office required.
Salary Range:
$209,000 - $242,000/year based on skills and experience.
EEOC Statement:
Alterome Therapeutics, Inc. is an equal opportunity employer committed to building a diverse and inclusive organization. We measure each applicant, candidate, and employee based on their qualifications for the role, regardless of age, sex, religion, sexual orientation, gender identity, national origin, Veteran status, disability, and/or any other protected class characteristics. Furthermore, Alterome is committed to achieving all business objectives in compliance with all federal, state, and local laws.
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