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Servier Pharmaceuticals
Boston, Massachusetts, United States
23 hours ago

Description

About Servier Pharmaceuticals:

We’re an organization, committed to modeling diversity, equity, and inclusion for the entire industry, and to maintaining an inclusive environment with equitable treatment for all. We are interested in growing our team with passionate, committed, and innovative individuals. We encourage all to apply to our open roles and are always willing to consider skills and experiences outside of what is listed in the job description.

SUMMARY OF ROLE:

The Senior Manager of Clinical Data Management will execute data deliverables for all phases of clinical trials and programs as part of the clinical operations group. This role will proactively participate within cross functional teams of internal clinical colleagues as well as external contract research organizations and other data vendors, driving end-to-end data quality and integrity from source through to submission. The Sr. Manager of Clinical Data Management will also lead or contribute to the development of departmental documents and procedures.

Specific Responsibilities:

  • Function as internal DM Study lead, overseeing all data management activities performed by CROs including generation and review of metric status and patient tracking reports; ensure major DM deliverables and milestones are met
  • Assist in review of vendor proposals, budgets, scopes of work; Provide input to protocols, and other clinical study documents during development
  • Review and manage key documents such as data management plan, guidelines for CRF completion, data review, SAE reconciliation, and data audits
  • Following CDISC conventions, oversee or perform eCRF design and annotation, database design specifications
  • Develop or oversee CRO generation of data edit check specifications (DVS); Participate in user acceptance testing (UAT) of the clinical database, including edit check testing
  • Create specifications for internal study team data review plan (IDRP); develop Protocol Deviation specifications document with input from study team
  • Work with SAS and/or clinical systems programming to produce in-process data reports and data visualization tools to facilitate decision making on clinical trials (e.g., safety reviews)
  • Lead internal study team in data review; Perform data review for quality issues and general data trends; generate queries as necessary
  • Define/oversee data transfer specifications for external data sources (labs, ECGs, PK) and transfer of data; oversee CRO lab reconciliation with clinical database
  • Study DM liaison with cross-functional team members and external vendors to ensure completion of all timelines and study-related tasks; Ability to work independently within a cross-functional team environment
  • May give Data Management presentations and/or training at investigator or other meetings
  • Lead and/or participate in development and implementation of departmental initiatives. Develop or improve data management SOPs and guidelines
  • May function as a resource or mentor for more junior colleagues


Requirements

Skills and Education:

  • Bachelor’s degree with 8+ years clinical data management experience in a biotech/pharmaceutical/CRO environment or equivalent experience
  • Interest in working in international environment with global colleagues
  • Experience using EDC (preferably Medidata), vendor data transfer process and integration
  • Experience as a lead CDM, managing studies from start up through DB lock and study close out
  • Strong knowledge of ICH GCP, FDA guidelines and of industry standards, including CDISC
  • Experience in oncology therapeutic areas (solid tumor and/or hematologic cancer)
  • Demonstrated organizational, leadership and oversight capabilities in a team setting

Other Relevant Information:

  • Preferably local candidate to Boston area
  • Small amount of travel may be required

Job Information

  • Job ID: 59442651
  • Location:
    Boston, Massachusetts, United States
  • Position Title: Senior Manager, Clinical Data Management
  • Company Name: Servier Pharmaceuticals
  • Primary Area of Job Responsibility: Clinical
  • Job Type: Full-Time
  • Job Duration: Indefinite
  • Required Travel: 0-10%
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