- 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 highly 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.
- 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
- 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)
- 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 8+ 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)
- Patients - We are committed to improving the lives of patients living with cancer. They are the driving force behind everything we do.
- Accountability - We demand accountability for our actions, behaviors, and performance. We recognize our duty to maintain a culture that embraces the uniqueness of our people and finds strength in our differences.
- Transparency - We strive to provide full visibility to internal and external stakeholders for a complete picture of what we are doing and why.
- Honesty and Integrity - Trust and mutual respect are essential aspects of our culture. We act with honesty and integrity in all facets of our business, and this serves as the foundation of our work and interactions with others.
- Stewardship - We are respectful of the resources entrusted to us by the investment community. We act thoughtfully and allocate resources responsibly in seeking to create value for our shareholders.
- Lead from where you are - regardless of role or level, we motivate each other to achieve common goals.
- Drive business results - we navigate forward with our eye on the highest priorities.
- Partner and collaborate - we cultivate relationships and value ideas, regardless of where they are coming from, to achieve more together.
- Continuously evolve and improve - we try, we learn, we revise and try again.
- 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
- [if applicable] Car allowance
-
Manager Data Management
5 days ago
ClinLab Staffing Cambridge, United StatesMANAGER DATA MANAGEMENT · Full-time Regular · Cambridge, MA, US · RESPONSIBILITIES · Manage and supervise a team of Clinical Data Managers (CDMs) · Oversee each project assigned to the team · QC each deliverable prior to sending to internal or external clients · Prepare and prese ...
-
Clinical Data Manager 2032279
5 days ago
Stratacuity: Proven Scientific Placement Watertown, United StatesLocation: Watertown, MA (Hybrid/Remote) · Science: Small Molecule · Therapeutic Area: Oncology · Job Overview: This role will independently manage and prioritize clinical study data procedures while providing expert guidance across international teams, effectively maintaining ove ...
-
Manager, Clinical Data Management
4 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
1 week 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 ...
-
Clinical Data Manager
1 week ago
Apex Systems Watertown, United StatesClinical Data Manager · Location:Watertown, MA (Hybrid/Remote) · Science:Small Molecule · Therapeutic Area:Oncology · Job Overview: This role will independently manage and prioritize clinical study data procedures while providing expert guidance across international teams, ef ...
-
Senior Manager, Data Management
1 week ago
Apellis Pharmaceuticals Watertown, 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
6 days ago
Deciphera Pharmaceuticals Watertown, United StatesJob Description · We are seeking a Manager to Lead Clinical Data Management (CDM) activities for clinical studies or a clinical program. This position will report to the Associate Director/Director of CDM and work on-site at our Waltham, MA office. Deciphera embraces a flexible ...
-
Manager, Data Science
2 days ago
ZoomInfo Technologies LLC Watertown, United StatesAt ZoomInfo, we encourage creativity, value innovation, demand teamwork, expect accountability and cherish results. We value your take charge, take initiative, get stuff done attitude and will help you unlock your growth potential. One great choice can change everything. Thrive w ...
-
Clinical Data Manager
1 week ago
Apex Systems Watertown, United StatesClinical Data Manager Location:Watertown, MA (Hybrid/Remote)Science:Small MoleculeTherapeutic Area:OncologyJob Overview: This role will independently manage and prioritize clinical study data procedures while providing expert guidance across international teams, effectively maint ...
-
Manager Clinical Data Management
5 days ago
Thor Companies Cambridge, United StatesThis is an amazing opportunity for a data manager with strong leadership skills to lead projects and supervise a team of Clinical Data Managers. My client is seeking a professional with excellent communication abilities and a proven track record in clinical operations, data manag ...
-
Project and Data Manager
3 weeks 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 ...
-
manager data management
1 day 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 Director, Clinical Data Management
3 days ago
C4 Therapeutics Watertown, United StatesAbout C4 Therapeutics: · C4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients' lives. C4T is leveraging i ...
-
Senior Manager, Data Management
1 day 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 ...
-
Data Manager
3 weeks 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 ...
-
Clinical Data Manager
2 weeks 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 ...
-
Sr. Manager, Clinical Data Management
4 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, Data Science
2 days ago
ZoomInfo Technologies LLC Waltham, United StatesAt ZoomInfo, we encourage creativity, value innovation, demand teamwork, expect accountability and cherish results. We value your take charge, take initiative, get stuff done attitude and will help you unlock your growth potential. One great choice can change everything. Thrive w ...
-
Sr. Manager, Clinical Data Management
1 week ago
Deciphera Pharmaceuticals Watertown, United StatesDeciphera 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 d ...
-
Clinical Data Manager
4 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 - Watertown, United States - Deciphera Pharmaceuticals
Description
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 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.
Job Description
We are seeking a Manager to Lead Clinical Data Management (CDM) activities for clinical studies or a clinical program. 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.
We offer an outstanding culture and opportunity for personal and professional growth based on our "PATHS" Core Values:
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.
