- 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
- Bachelor'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
- Non-accrual paid time off
- Summer vacation bonus
- Global, company-wide summer and winter shutdowns
- An annual lifestyle allowance
- Monthly cell phone stipend
- Internal rewards and recognition program
- Medical, Dental, and Vision Insurance
- 401(k) retirement plan with company match
- Life and Supplemental life insurance for family
- Short- and Long-Term Disability insurance
- ESPP offering
- Health savings account with company contribution
- Flexible spending account for either health care and/or dependent care.
- Family planning benefit
- Generous parental leave
-
Manager, Data Science
2 weeks ago
ZoomInfo Waltham, United StatesZoominfo is actively seeking a hands-on Manager of Data Science to join our Enterprise Data and Analytics team. In this strategic role, you will lead efforts to analyze and harness diverse datasets across our organization, with a primary focus on leveraging data science and machi ...
-
Sr. Manager, Enterprise Data
2 weeks ago
NetApp Waltham, United StatesTitle: Sr. Manager, Enterprise Data & Analytics · Location: Research Triangle Park, NC, US, 27709 · Requisition ID: About NetApp · We're forward-thinking technology people with heart. We make our own rules, drive our own opportunities, and try to approach every challenge with ...
-
Senior Manager, Data Management
3 weeks ago
Apellis Pharmaceuticals Waltham, United StatesPosition Summary: · The Senior Manager, Data Management acts as the Lead Data Manager for multiple clinical studies and/or a clinical development program. They provide leadership and guidance for all phases of clinical studies from the EDC study design through to study closeout. ...
-
Manager, Clinical Data Management
2 weeks ago
Deciphera Pharmaceuticals Waltham, United StatesJob Description · Job DescriptionCompany Description · Deciphera 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 inhib ...
-
Senior Manager, Data Management
2 weeks ago
Apellis Waltham, United StatesJob Description · Job DescriptionPosition Summary: · The Senior Manager, Data Management acts as the Lead Data Manager for multiple clinical studies and/or a clinical development program. They provide leadership and guidance for all phases of clinical studies from the EDC study d ...
-
Clinical Data Manager
5 days ago
Katalyst Healthcares and Life Sciences Waltham, United StatesResponsibilities: ct as primary liaison between Company and CRO for Data Management. · Provide support and oversight for the CRO Data Management team. · Collaborate with the team on study design, protocol development, CRF design, statistical planning, and CSRs. · Review clinica ...
-
Clinical Data Manager
2 weeks ago
Dragonfly Therapeutics, Inc. Waltham, United StatesClinical Data Manager · Dragonfly Therapeutics seeks a Clinical Data Manager with relevant Clinical Data Management experience to join our Clinical group. This role will report to the Associate Director, Clinical Data Management. This role is responsible for the oversight of all ...
-
Manager, Clinical Data Management
2 weeks ago
Deciphera Pharmaceuticals Watertown, United StatesCompany 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 ...
-
Manager, Clinical Data Management
2 weeks ago
Deciphera Pharmaceuticals Watertown, United StatesCompany Description · Deciphera 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 ...
-
Senior Manager, Clinical Data
2 weeks ago
TScan Therapeutics Waltham, United StatesPosition Summary: · TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Senior Clinical Data Manager to oversee data management activities across our studie ...
-
Director, Data Management Services
4 days ago
Vita Data Sciences Waltham, United StatesVita Global Sciences provides unparalleled professional services in clinical data analytics and functional outsourcing. As an innovator in the Life Sciences space, Vita Global Sciences partners with clients to develop and deliver full service, scalable data solutions in the Pharm ...
-
Senior Manager, Clinical Data
2 weeks ago
TScan Therapeutics Waltham, United StatesJob Description · Job DescriptionPosition Summary: · TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Senior Clinical Data Manager to oversee data manage ...
-
Sr. Manager, Clinical Data Management
2 weeks ago
Deciphera Pharmaceuticals Watertown, United StatesCompany 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 ...
-
Project and Data Manager
1 week ago
Vinfen Cambridge, United States Full time - RegularJob Description · Schedule: Monday - Friday 9 am to 5 pm Salary: Mid$60,000 / year Reporting to the Senior Vice President, the Project and Data Manager will support the Psychiatric Rehabilitation Division's efforts to plan and manage initiatives and projects; develop and prese ...
-
Data Manager
1 week ago
University Instructors Boston, United StatesOverview · University Instructors (UI) is seeking a dynamic Manager of Data Services (MDS) to manage the data services team under the direction of the UI Executive Vice President. The MDS will oversee data governance which includes setting quality assurance measures to successfu ...
-
manager data management
2 weeks ago
Prometrika LLC Cambridge, United StatesJob Description · Job DescriptionPROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're driven by our passion for the human aspect of our wor ...
-
Senior Manager, Data Management
3 weeks ago
Apellis Waltham, United StatesJob Description · Job Description · Position Summary: · The Senior Manager, Data Management acts as the Lead Data Manager for multiple clinical studies and/or a clinical development program. They provide leadership and guidance for all phases of clinical studies from the EDC st ...
-
Manager/Sr Manager, Data Management
2 weeks ago
Innova Solutions Cambridge, United States Direct HireInnova Solutions Client is immediately hiring for a Manager/Sr Manager, Data Management · Position type: Full Time Perm · Location: Preferred location Cambridge, MA / Remote · Salary: $175K - $185K depending on experience and level, might go up on the salary for the right candida ...
-
Clinical Data Manager
2 weeks ago
Katalyst HealthCares & Life Sciences Waltham, United StatesResponsibilities: · Act as primary liaison between Company and CRO for Data Management. · Provide support and oversight for the CRO Data Management team. · Collaborate with the team on study design, protocol development, CRF design, statistical planning, and CSRs. · Review cl ...
-
Manager, Clinical Data Management
6 days ago
Deciphera Pharmaceuticals Waltham, United StatesCompany 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 ...
Sr. Manager, Clinical Data Management - Waltham, United States - Deciphera Pharmaceuticals
Description
Job Description
Job DescriptionCompany 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:
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.
Deciphera offers a comprehensive benefits package that includes but is not limited to the following:
Deciphera (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 INFORMATION
Deciphera 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.