Associate Director Data Management
Associate Director Data Management
Posted on :
24-01-2025
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
24-01-2025
Job Description
Job Title: Associate Director Data Management
Job Location: United States
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
Spyre Therapeutics is a biotechnology company that aims to create nextgeneration inflammatory bowel disease (IBD) and other immunemediated disease products by combining bestinclass antibody engineering rational therapeutic combinations and precision medicine approaches. Spyre’s pipeline includes extended halflife antibodies targeting α4β7 TL1A and IL23.
Role Summary
We are seeking analytical and detailoriented individual who will serve as the lead clinical data manager for clinical studies as assigned and is responsible for providing input to protocols leading in design and review case report forms assisting development and validation of clinical databases and systems and performing all data management related activities.
Key Responsibilities
As an equal opportunity employer Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin gender age sexual orientation physical or mental disability genetic information or characteristic gender identity and expression veteran status or other nonjobrelated characteristics or other prohibited grounds specified in applicable federal state and local laws. We also embrace differences in experience and background and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing lifechanging products for patients.
Spyre Therapeutics along with other biotech companies has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email.
Please also be aware that all job postings will be listed on our website at spyre.com/careers/.
Role Summary
We are seeking analytical and detailoriented individual who will serve as the lead clinical data manager for clinical studies as assigned and is responsible for providing input to protocols leading in design and review case report forms assisting development and validation of clinical databases and systems and performing all data management related activities.
Key Responsibilities
- Perform data management study activities and manage timelines during study startup study conduct database lock and documentation archival
- Conduct oversight of and guidance to data management CROs to ensure that data management documents and tasks are completed and delivered in accordance with timelines and data quality standards
- Oversee and drive development of study related data management deliverables (e.g. eCRF DTA etc.)
- Participate in the implementation and UAT of clinical systems (e.g. EDC IRT eCOA)
- Coordinate cross functional data review and provide proactively review of data trends and issue resolution
- Bachelor’s degree is required
- 10 years of data management experience in the pharmaceutical biotech or CRO industry
- Handon knowledge and experience in data management activities such as CRF and EDC design review and validation from various vendors
- Knowledge of realtime data flow across clinical systems
- Knowledge of SDTM and experience in transforming raw data into these standards
- Knowledge of GCP ICH and regulatory requirements
- Successful track record of working independently in a matrixed organization or in a startup environment providing effective solutions to emerging problems
- Excellent interpersonal communication skills along with organizational skills
- Opportunity to work in a fastpaced dynamic environment where you help shape the culture of our young company contribute broadly to advance meaningful medicines and learn quickly.
- Market competitive compensation and benefits package including base salary performance bonus equity grant opportunities health welfare & retirement benefits.
- Unlimited PTO
- Two oneweek companywide shutdowns each
- Commitment to provide professional development opportunities.
- Remote working environment with frequent inperson meetings to address complex problems and build relationships.
As an equal opportunity employer Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin gender age sexual orientation physical or mental disability genetic information or characteristic gender identity and expression veteran status or other nonjobrelated characteristics or other prohibited grounds specified in applicable federal state and local laws. We also embrace differences in experience and background and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing lifechanging products for patients.
Spyre Therapeutics along with other biotech companies has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email.
Please also be aware that all job postings will be listed on our website at spyre.com/careers/.
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Employment Type
Full Time
Key Skills
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