*Need Lead Clinical Data Manager, Need EAD-GC,GC and USC And Local


Position:Lead Clinical Data Manager
Location:Lexington, MA
Duration:6 to 12+ months

The Clinical Data Manager will have a demonstrated ability to oversee the
data management activities across a single clinical program or group of
related studies.
Provides Data Management leadership and expertise to project and study
teams. Will have an good knowledge of the end to end clinical research and
data management processes, as well as global regulatory and industry rules
and guidances  (i.e. ICH, GCP) to support drug development processes and
global project submissions through to approval.
Responsible for managing data management components of project and study
budgets and vendor performance.
May mentors team members and more junior staff and may direct activities of
contract Data Manager staff.
Takes leadership role in project implementation As a member of the clinical
study or project team, ensures oversight of the Data Management CRO;
Provides status reports/updates, resolves disputes, and ensures timely
acquisition of high quality deliverables from the CRO Provides Data
Management expertise to the team in identifying opportunities for process
and budgetary optimization Coordinates with Biostatistics and Statistical
Programming to ensure appropriate design, documentation, testing and
implementation of SAS data deliverables according to internal and
regulatory standards Works with team members via matrix relationships
(internally or at CROs) by directing work, resolving problems and/or
providing guidance
B.S. degree in Scientific or related field is preferred. Minimum of 5-7
years as a Senior Data Manager within a Data Management organization
Experience with leading teams and/or organizations. CCDM certification
Will sit in real world late phase group which runs Non interventional
trials, safety trials, registry trials.
Must have significant Lead Clinical Data management experience Team is 100%
outsourced, meaning candidate will not do actual data work but wi

Alvin Stuart Recruiter

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