Repare Therapeutics, Inc.
Senior Manager, Clinical Data Management
Repare Therapeutics, Inc., Cambridge, Massachusetts, us, 02140
Senior Manager, Clinical Data Management
Repare Therapeutics - Cambridge, MA, 101 Main St, Cambridge, Massachusetts, United States of America
Req #6Friday, October 25, 2024Repare Therapeutics (Nasdaq: RPTX) is a leading clinical-stage precision oncology company enabled by our proprietary synthetic lethality approach to discovering and developing novel therapeutics. We use our genome-wide, CRISPR-enabled SNIPRx platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair.Our company was founded in 2016 by field-leading academics to systematically employ synthetic lethality insights and platforms and develop new precision oncology medicines.Repare is growing at a rapid pace with challenging and exciting opportunities for experienced professionals. We look for scientific and business professionals who are highly motivated, collaborative and, above all, share our passionate interest in fighting cancer and improving patients’ lives.About the Role:We are currently seeking a Senior Manager, Clinical Data Management. The level of this position will reflect the experience and seniority of the candidate. This role will be a key member of the Clinical Team and will ensure clinical data collection is aligned with the clinical trial requirements, promotes consistency across the REPARE portfolio and achieves high quality data for analysis and reporting.You will, in close collaboration with the Biometrics Vendor partner and the Clinical Team, be accountable for clinical data management start-up activities across one or more trial drug programs. You will be responsible for the planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data. You will provide oversight of the Biometric Partner and the services they provide to Repare related to data management start-up activities through close out. Further, the Senior Manager, Clinical Data Management will support the development and optimization of processes and tools to enable success of the Clinical Development Organization.Responsibilities:The key responsibilities include, but are not limited to:Maintaining a close collaboration with internal key stakeholders, such as translational and clinical scientists, project leaders, biostatisticians and programmers.Providing input to trial design, protocols and amendments to ensure protocol enables proper data collection to support analysis and reporting needs.Responsible for timely and high-quality data management deliverables supporting the portfolio.Confirms asset and study level strategies and services are being implemented at the study level and ensuring consistency across trials, CROs and vendors.Conducts oversight of data management activities performed by the CROs and other 3rd party vendors (IRT, Safety, Lab, etc.) to meet Repare’s obligations and business objectives. Activities include from protocol synopsis through database release and submission.Serves as a first point of contact for CRO DM partners when collaboration is needed to ensure established milestones and deliverables are met with the highest degree of quality.Serves as an expert for clinical data management best practices.Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks.Tracks study deliverables and evaluates study metrics to mitigate risk for major data management deliverables and milestones.Ensuring overall TMF inspection readiness specific to Data Management.Requirements:Minimum of 8 years’ experience as a data management lead in the pharmaceutical/CRO industry across all trial phases within the oncology therapeutic area.Bachelor’s degree in life science or discipline, advanced degree preferred.In depth understanding of the complex and interdependent relationships between protocol development, data collection and analysis and reporting in complex oncology trial.In depth knowledge of industry leading eCRF tools and well versed in industry trends and emerging technologies supporting data collection as well as reviewing and contributing to all relevant DM documentation (i.e. lead CRF creation, DMP, eCRF Completion Guidelines, DTS, SAE Reconciliation Plan, etc.).Proficient experience using commercial clinical data management systems and/or EDC products (Medidata Rave/ Zelta preferred) for all activities from start-up through database lock including hands on UAT, data review, etc.Knowledge of CDISC requirements; understanding of data collection requirements in oncology trials is required; understanding of SDTM requirements.Experience utilizing clinical review and analysis software (jReview strongly preferred).Strong project management; Exhibits expertise in metrics analysis and reporting methodologies.Extensive hands-on experience with clinical data management practices within oncology.Knowledge of medical terminology, local laboratory reference ranges, preferably within oncology.Knowledge of dictionary structures (MedDRA, WHO Drug, etc.).Ability to develop strong and productive working relationships with internal and external key stakeholders.Knowledge of clinical research, FDA & ICH, GCP, GCDMP, related regulatory requirements.Proven experience in hands on DM tasks as well as DM vendor oversight to meet aggressive timelines of high-quality data deliverables.Ability to handle multiple development programs simultaneously.Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills.Contribute to the growth and development of the in-house DM team.Repare Therapeutics is an equal opportunity employer committed to non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, gender identity, pregnancy, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Accommodations are available on request for candidates taking part in all aspects of the selection process. We appreciate your interest in working for Repare Therapeutics and look forward to connecting with you.
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Repare Therapeutics - Cambridge, MA, 101 Main St, Cambridge, Massachusetts, United States of America
Req #6Friday, October 25, 2024Repare Therapeutics (Nasdaq: RPTX) is a leading clinical-stage precision oncology company enabled by our proprietary synthetic lethality approach to discovering and developing novel therapeutics. We use our genome-wide, CRISPR-enabled SNIPRx platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair.Our company was founded in 2016 by field-leading academics to systematically employ synthetic lethality insights and platforms and develop new precision oncology medicines.Repare is growing at a rapid pace with challenging and exciting opportunities for experienced professionals. We look for scientific and business professionals who are highly motivated, collaborative and, above all, share our passionate interest in fighting cancer and improving patients’ lives.About the Role:We are currently seeking a Senior Manager, Clinical Data Management. The level of this position will reflect the experience and seniority of the candidate. This role will be a key member of the Clinical Team and will ensure clinical data collection is aligned with the clinical trial requirements, promotes consistency across the REPARE portfolio and achieves high quality data for analysis and reporting.You will, in close collaboration with the Biometrics Vendor partner and the Clinical Team, be accountable for clinical data management start-up activities across one or more trial drug programs. You will be responsible for the planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data. You will provide oversight of the Biometric Partner and the services they provide to Repare related to data management start-up activities through close out. Further, the Senior Manager, Clinical Data Management will support the development and optimization of processes and tools to enable success of the Clinical Development Organization.Responsibilities:The key responsibilities include, but are not limited to:Maintaining a close collaboration with internal key stakeholders, such as translational and clinical scientists, project leaders, biostatisticians and programmers.Providing input to trial design, protocols and amendments to ensure protocol enables proper data collection to support analysis and reporting needs.Responsible for timely and high-quality data management deliverables supporting the portfolio.Confirms asset and study level strategies and services are being implemented at the study level and ensuring consistency across trials, CROs and vendors.Conducts oversight of data management activities performed by the CROs and other 3rd party vendors (IRT, Safety, Lab, etc.) to meet Repare’s obligations and business objectives. Activities include from protocol synopsis through database release and submission.Serves as a first point of contact for CRO DM partners when collaboration is needed to ensure established milestones and deliverables are met with the highest degree of quality.Serves as an expert for clinical data management best practices.Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks.Tracks study deliverables and evaluates study metrics to mitigate risk for major data management deliverables and milestones.Ensuring overall TMF inspection readiness specific to Data Management.Requirements:Minimum of 8 years’ experience as a data management lead in the pharmaceutical/CRO industry across all trial phases within the oncology therapeutic area.Bachelor’s degree in life science or discipline, advanced degree preferred.In depth understanding of the complex and interdependent relationships between protocol development, data collection and analysis and reporting in complex oncology trial.In depth knowledge of industry leading eCRF tools and well versed in industry trends and emerging technologies supporting data collection as well as reviewing and contributing to all relevant DM documentation (i.e. lead CRF creation, DMP, eCRF Completion Guidelines, DTS, SAE Reconciliation Plan, etc.).Proficient experience using commercial clinical data management systems and/or EDC products (Medidata Rave/ Zelta preferred) for all activities from start-up through database lock including hands on UAT, data review, etc.Knowledge of CDISC requirements; understanding of data collection requirements in oncology trials is required; understanding of SDTM requirements.Experience utilizing clinical review and analysis software (jReview strongly preferred).Strong project management; Exhibits expertise in metrics analysis and reporting methodologies.Extensive hands-on experience with clinical data management practices within oncology.Knowledge of medical terminology, local laboratory reference ranges, preferably within oncology.Knowledge of dictionary structures (MedDRA, WHO Drug, etc.).Ability to develop strong and productive working relationships with internal and external key stakeholders.Knowledge of clinical research, FDA & ICH, GCP, GCDMP, related regulatory requirements.Proven experience in hands on DM tasks as well as DM vendor oversight to meet aggressive timelines of high-quality data deliverables.Ability to handle multiple development programs simultaneously.Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills.Contribute to the growth and development of the in-house DM team.Repare Therapeutics is an equal opportunity employer committed to non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, gender identity, pregnancy, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Accommodations are available on request for candidates taking part in all aspects of the selection process. We appreciate your interest in working for Repare Therapeutics and look forward to connecting with you.
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