Senior Manager, Clinical Data Management at Deciphera Pharmaceuticals
Waltham, MA 02451
About the Job
Company DescriptionDeciphera, a member of ONO, is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer
We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.Enabled by our proprietary drug discovery platform, Deciphera has developed a diverse pipeline of wholly-owned drug candidates
QINLOCK (ripretinib) is Deciphera’s switch control inhibitor developed for the treatment of fourth-line GIST
QINLOCK is approved in Australia, Canada, China, the European Union, Hong Kong, Switzerland, Taiwan, the United States, and the United Kingdom. We wholly own QINLOCK and all of our drug candidates with the exception of a development and commercialization out-license agreement for QINLOCK in Greater China
In addition to QINLOCK, we have identified and advanced multiple product candidates from our platform into clinical studies, including vimseltinib and DCC-3116. See here for more details on our portfolio.We offer an outstanding culture and opportunity for personal and professional growth guided by our “PATHS” Core Values and how we work together
We are proud to be Great Place to Work Certified 2023 and rank #25 on Fortune’s Best Places to Work Small and Midsized Biotech Companies in 2023
Find more details about our award-winning culture here. Job DescriptionWe are seeking a Senior Manager to lead Clinical Data Management (CDM) activities for clinical studies or clinical program(s)
This position will report to the Associate Director/Director of CDM and work on-site at our Waltham, MA office
Deciphera embraces a flexible workplace
You will work out of our Waltham, Massachusetts office
Deciphera expects a minimum number of in-office days
Specific days spent in the office should be determined in conjunction with your manager.What You’ll Do: May simultaneously function as lead CDM for multiple clinical trials or oversee the data management across a programAccountable for the data quality and data integrity for complex or pivotal clinical studiesOversee the work of the outsourced CDM vendor for assigned projectsMay contribute to vendor selection and management to ensure performance is consistent with Deciphera standards.May review invoicesForecast timelines and resources required to complete study-specific tasks on time and with high qualityWork collaboratively with stakeholders in Medical Affairs, Regulatory, PV to determine dates of program data deliverables.Provide guidance on clinical data management to CDM staff, study teams, vendors, and managementManage the escalation of study related issues and communicate as appropriate with managementPresent ongoing study updates to managementMay supervise one or several CDM staff membersPlan the data acquisition for the clinical studies in the program, ensuring the computerized data systems are adequate and fit for purpose and the testing aligns with the risk and criticality of the data and the validation needs of the computerized data systemEnsure the activities described in the Data Management Plan (DMP) are executed in accordance with the DMP, including data acquisition, data transfer, data reconciliation and review, medical coding, data extract and rolling data freeze, data lock and database lockEnsure that CDM documentation is filed into the Trial Master File (TMF) according to SOPs and the study plans; review CDM files for completeness and accuracyLead inspection activities for CDM and manage any findings to resolution.Active participant in the development and revision of Standard Operating Procedures (SOPs)Define metrics to measure clinical trial database quality, site and vendor performance and implement those metrics in the clinical trialsAnalyze metrics across projects and programs; escalate or inform management and cross functional colleagues to trends.Facilitate resolution of operational problems, issues, obstacles and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders.Assist with development of therapeutic area standards for Case Report Forms and Edit ChecksAssist in the coordination of the acquisition and development of tools to support data management tasks internally and externally with DM vendors; this may include development of specifications, validation documentation or perform validationQualificationsWhat You’ll Bring:Bachelor’s or master’s degree, plus 10+ years of experienceExcellent communication and critical thinking skillsExcellent organizational and project management skillsFamiliarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)Familiarity with CDISC standardsAdditional InformationDeciphera offers a comprehensive benefits package that includes but is not limited to the following:Non-accrual paid time offSummer vacation bonusGlobal, company-wide summer and winter shutdownsAn annual lifestyle allowanceMonthly cell phone stipendInternal rewards and recognition programMedical, Dental, and Vision Insurance401(k) retirement plan with company matchLife and Supplemental life insurance for familyShort and Long Term Disability insuranceHealth savings account with company contributionFlexible spending account for either health care and/or dependent care.Family planning benefitGenerous parental leave[if applicable] Car allowanceDeciphera, a member of ONO, is a company headquartered in Waltham, Massachusetts
Our state-of-the-art research facility is located in Lawrence, Kansas and our European operations are run out of Switzerland. EQUAL EMPLOYMENT OPPORTUNITY INFORMATIONDeciphera is committed to equal employment opportunity and values diversity
To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a confidential survey at the end of this application
Providing this information is optional
It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment
This information will also be treated confidentially. Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis.SummaryType: Full-timeFunction: ScienceExperience level: Mid-Senior LevelIndustry: Pharmaceuticals
We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.Enabled by our proprietary drug discovery platform, Deciphera has developed a diverse pipeline of wholly-owned drug candidates
QINLOCK (ripretinib) is Deciphera’s switch control inhibitor developed for the treatment of fourth-line GIST
QINLOCK is approved in Australia, Canada, China, the European Union, Hong Kong, Switzerland, Taiwan, the United States, and the United Kingdom. We wholly own QINLOCK and all of our drug candidates with the exception of a development and commercialization out-license agreement for QINLOCK in Greater China
In addition to QINLOCK, we have identified and advanced multiple product candidates from our platform into clinical studies, including vimseltinib and DCC-3116. See here for more details on our portfolio.We offer an outstanding culture and opportunity for personal and professional growth guided by our “PATHS” Core Values and how we work together
We are proud to be Great Place to Work Certified 2023 and rank #25 on Fortune’s Best Places to Work Small and Midsized Biotech Companies in 2023
Find more details about our award-winning culture here. Job DescriptionWe are seeking a Senior Manager to lead Clinical Data Management (CDM) activities for clinical studies or clinical program(s)
This position will report to the Associate Director/Director of CDM and work on-site at our Waltham, MA office
Deciphera embraces a flexible workplace
You will work out of our Waltham, Massachusetts office
Deciphera expects a minimum number of in-office days
Specific days spent in the office should be determined in conjunction with your manager.What You’ll Do: May simultaneously function as lead CDM for multiple clinical trials or oversee the data management across a programAccountable for the data quality and data integrity for complex or pivotal clinical studiesOversee the work of the outsourced CDM vendor for assigned projectsMay contribute to vendor selection and management to ensure performance is consistent with Deciphera standards.May review invoicesForecast timelines and resources required to complete study-specific tasks on time and with high qualityWork collaboratively with stakeholders in Medical Affairs, Regulatory, PV to determine dates of program data deliverables.Provide guidance on clinical data management to CDM staff, study teams, vendors, and managementManage the escalation of study related issues and communicate as appropriate with managementPresent ongoing study updates to managementMay supervise one or several CDM staff membersPlan the data acquisition for the clinical studies in the program, ensuring the computerized data systems are adequate and fit for purpose and the testing aligns with the risk and criticality of the data and the validation needs of the computerized data systemEnsure the activities described in the Data Management Plan (DMP) are executed in accordance with the DMP, including data acquisition, data transfer, data reconciliation and review, medical coding, data extract and rolling data freeze, data lock and database lockEnsure that CDM documentation is filed into the Trial Master File (TMF) according to SOPs and the study plans; review CDM files for completeness and accuracyLead inspection activities for CDM and manage any findings to resolution.Active participant in the development and revision of Standard Operating Procedures (SOPs)Define metrics to measure clinical trial database quality, site and vendor performance and implement those metrics in the clinical trialsAnalyze metrics across projects and programs; escalate or inform management and cross functional colleagues to trends.Facilitate resolution of operational problems, issues, obstacles and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders.Assist with development of therapeutic area standards for Case Report Forms and Edit ChecksAssist in the coordination of the acquisition and development of tools to support data management tasks internally and externally with DM vendors; this may include development of specifications, validation documentation or perform validationQualificationsWhat You’ll Bring:Bachelor’s or master’s degree, plus 10+ years of experienceExcellent communication and critical thinking skillsExcellent organizational and project management skillsFamiliarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)Familiarity with CDISC standardsAdditional InformationDeciphera offers a comprehensive benefits package that includes but is not limited to the following:Non-accrual paid time offSummer vacation bonusGlobal, company-wide summer and winter shutdownsAn annual lifestyle allowanceMonthly cell phone stipendInternal rewards and recognition programMedical, Dental, and Vision Insurance401(k) retirement plan with company matchLife and Supplemental life insurance for familyShort and Long Term Disability insuranceHealth savings account with company contributionFlexible spending account for either health care and/or dependent care.Family planning benefitGenerous parental leave[if applicable] Car allowanceDeciphera, a member of ONO, is a company headquartered in Waltham, Massachusetts
Our state-of-the-art research facility is located in Lawrence, Kansas and our European operations are run out of Switzerland. EQUAL EMPLOYMENT OPPORTUNITY INFORMATIONDeciphera is committed to equal employment opportunity and values diversity
To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a confidential survey at the end of this application
Providing this information is optional
It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment
This information will also be treated confidentially. Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis.SummaryType: Full-timeFunction: ScienceExperience level: Mid-Senior LevelIndustry: Pharmaceuticals
