Sr. Manager, Clinical Data Management
Company DescriptionDeciphera 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 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.
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 program Accountable for the data quality and data integrity for complex or pivotal clinical studies Oversee the work of the outsourced CDM vendor for assigned projects May contribute to vendor selection and management to ensure performance is consistent with Deciphera standards.
May review invoices Forecast timelines and resources required to complete study-specific tasks on time and with high quality Work 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 management Manage the escalation of study related issues and communicate as appropriate with management Present ongoing study updates to management May supervise one or several CDM staff members Plan 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 system Ensure 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 lock Ensure that CDM documentation is filed into the Trial Master File (TMF) according to SOPs and the study plans; review CDM files for completeness and accuracy Lead 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 trials Analyze 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 Checks Assist 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 validation QualificationsBachelor s or master s degree, plus 10
years of experience Excellent communication and critical thinking skills Excellent organizational and project management skills Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)Familiarity with CDISC standards Additional InformationWe 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.
Deciphera 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 insuranceESPP offeringHealth savings account with company contributionFlexible spending account for either health care and/or dependent care.
Family planning benefitGenerous parental leaveDeciphera (NASDAQ:
DCPH) is a publicly traded company headquartered in Waltham, Massachusetts.
Our state-of-the-art research facility is 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:
AssociateIndustry:
Pharmaceuticals.
Estimated Salary: $20 to $28 per hour based on qualifications.
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 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.
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 program Accountable for the data quality and data integrity for complex or pivotal clinical studies Oversee the work of the outsourced CDM vendor for assigned projects May contribute to vendor selection and management to ensure performance is consistent with Deciphera standards.
May review invoices Forecast timelines and resources required to complete study-specific tasks on time and with high quality Work 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 management Manage the escalation of study related issues and communicate as appropriate with management Present ongoing study updates to management May supervise one or several CDM staff members Plan 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 system Ensure 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 lock Ensure that CDM documentation is filed into the Trial Master File (TMF) according to SOPs and the study plans; review CDM files for completeness and accuracy Lead 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 trials Analyze 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 Checks Assist 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 validation QualificationsBachelor s or master s degree, plus 10
years of experience Excellent communication and critical thinking skills Excellent organizational and project management skills Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)Familiarity with CDISC standards Additional InformationWe 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.
Deciphera 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 insuranceESPP offeringHealth savings account with company contributionFlexible spending account for either health care and/or dependent care.
Family planning benefitGenerous parental leaveDeciphera (NASDAQ:
DCPH) is a publicly traded company headquartered in Waltham, Massachusetts.
Our state-of-the-art research facility is 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:
AssociateIndustry:
Pharmaceuticals.
Estimated Salary: $20 to $28 per hour based on qualifications.
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