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Senior Manager, Clinical Data Management
Spero Therapeutics Cambridge, MA
Full Time | Pharmaceutical 3 Months Ago
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Spero Therapeutics is Hiring a Senior Manager, Clinical Data Management Near Cambridge, MA

About Us

Spero Therapeutics (Nasdaq: SPRO) is a multi-asset pre-commercial stage biopharmaceutical company in Cambridge, Mass. We are highly committed to advancing novel treatment approaches for bacterial infections with a world-class team of biotech and drug development experts. The company has a pipeline of novel and highly differentiated antibacterial and rare disease product candidates focused on patients with unmet need associated with multi-drug resistant (MDR) bacterial infections. Spero’s lead product candidate, SPR720, is an oral antimicrobial agent in development for the treatment of nontuberculous mycobacterial (NTM) pulmonary disease, a rare orphan disease. Spero’s partnership directed programs consist of SPR206 and tebipenem HBr. SPR206, is an IV-administered agent being developed as an innovative option to treat MDR Gram-negative bacterial infections and tebipenem HBr, is an oral carbapenem being developed as the first oral carbapenem antibiotic for use in complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). In September 2022, Spero announced an exclusive license agreement with GSK for worldwide rights of tebipenem HBr, except for Japan and certain Asian countries. We believe that our novel product candidates will have a meaningful impact on patient health and significant commercial applications for treating MDR infections in hospitals and community settings.

Overview

The Senior Manager, Clinical Data Management will have diverse data management and clinical trial experiences, be hands-on and motivated to support and contribute broadly to Data Management functional initiatives, and actively participate in the development, implementation, and management of data collection, ensuring its highest quality and integrity. Motivated and willing to work in partnership, guide and support cross-functional teams, and apply dynamic and creative approaches in the lifecycle of clinical trial data.

What you'll do

  • Provide leadership in establishing and meeting project management requirements by incorporating cross-functional processes with clinical operations, medical, clinical science, biostatistics, regulatory, quality compliance, etc.
  • Assist in the development and implementation of data management standard working practices along with preparations and requirements for regulatory inspections and or submissions.
  • Responsible for vendor performance, deliverables, and key measures
  • Comprehend and translate clinical team objectives into operational actions and maximize available technology platforms to assist in coordination, planning, and completing objectives.
  • Contribute toward establishing global data standards and governance, and authoring practices

Data Management Lead (directly and/or through vendor management)

  • Deliver content expertise as DM project manager/lead managing assigned study project timelines ensuring overall deliverables/timelines and vendor responsibilities are met
  • Provide leadership and content expertise for DM activities from start-up through statistical analysis stage of clinical studies to effectively manage data capture, review, and database lock activities.
  • Provide input into study protocols, SAPs, DSMB, etc. from a data management perspective
  • Handle data management deliverables including document creation of Data Management Plans, Data Validation Specifications, CRF Completion Guidelines, Transfer Specifications, Lab Specifications, etc.
  • Participate with vendors in UAT for database builds and or migrations to manage any impacts from mid-study updates to the EDC database.
  • Provides electronic case report forms (eCRFs) utilizing the Spero Standards Library and reviews updated designs for completeness, content, and database considerations
  • Facilitates meeting CDASH/SDTM data standardization guidance
  • Responsible for ensuring QC of outputs and data standards transformations are appropriately validated and documented
  • Perform data reviews for quality issues and general data trends
  • Establish data transfer guidelines for external data with CRO and vendor partners; ensure transfers and reconciliations are to plan
  • Manages outputs and metrics to track and report data/query status

What you'll need

  • BS in scientific, healthcare, medical, and or bioinformatics/computer science discipline.
  • Minimum of 7 years of proven career development, growth, and accomplishments in clinical data management/clinical trials.
  • Must have relevant technical skills, CRO oversight, and QA/QC; submission preparation experiences within the pharmaceutical/biotechnology industry is preferred.
  • Excellent organizational skills, highly collaborative & supportive, attention to detail, communication, time management, and flexible attitude with respect to work assignments and new learning with proven ability to interact in a team environment.
  • Proficient in data collection/reporting/analysis, related processes in using multiple EDC platforms (i.e., Medidata, ePRO, RDMSs, etc.)
  • Moderate to strong background with CDISC standards (CDASH/SDTM)
  • Knowledge of industry and regulatory standards (FDA and/or EMEA Regulations, ICH Guidelines, and GCP)
  • Comfortable in a fast-paced small company environment with the ability to manage a variety of projects simultaneously and handle rapidly changing information.
  • Self-starter and must function well under minimal supervision
  • Expert MS Office skills with a specific focus on word processing, formatting, tables, spreadsheets, presentations, graphics, slides, and templates, in addition to Adobe Acrobat.

By joining our committed and highly motivated team, you’ll experience a workplace culture that is inclusive, fair, challenging, supportive, and respectful. Spero’s culture is one that emphasizes “servant leadership,” or putting ego aside and working for the benefit of the team and our patients, and values our colleagues’ opinions and celebrates accomplishments in service of patients. Spero provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Spero requires all employees to be vaccinated against COVID-19 absent a bona fide medical reason or genuine religious belief relating to vaccinations. All employees must be in compliance with Spero Therapeutics’ COVID-19 vaccine policy at the time of employment.

Job Summary

JOB TYPE

Full Time

INDUSTRY

Pharmaceutical

POST DATE

12/01/2022

EXPIRATION DATE

12/19/2022

WEBSITE

sperotherapeutics.com

HEADQUARTERS

CAMBRIDGE, MA

SIZE

100 - 200

FOUNDED

2013

CEO

ANKIT MAHADEVIA

REVENUE

$5M - $10M

INDUSTRY

Pharmaceutical

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