Clinical Data Manager
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 a good knowledge of the end to end clinical research and data management processes, as well as global regulatory and industry rules and guidance (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
Accountability and Ownership:
?? Drives accountability at every possible level
?? Ensures Data Management CROs are delivering quality data and documentation on time, on budget and to Shire??s quality standards and SOPs
?? Reviews Data Management CRO performance measures and evaluates cost/benefit of actions taken to remedy or improve performance
?? Collaborates with CRO and study team members to identify and resolve issues impacting goal attainment.
Working hours: 8:00 AM - 4:00 PM
--Must be able to produce data management reports
--Strong attention to detail and accuracy is a must.
--Ability to read, analyze and interpret complex technical documents.
--Ability to present complex issues in oral and written form.
--Strong knowledge of MS Word, Excel, PowerPoint, Access and Outlook.
--Must be able to independently present complex information to departmental management, professional organizations, CROs and the medical community.
--Proven ability to manage and communicate effectively with research vendors including reviewing request for proposals, analyzing scope of work, budgeting and forecasting, responding to inquiries and complaints.
--Demonstrated ability to prioritize across work assignments.
--Proven ability to independently resolve problems.
--Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.
--Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands.
--Ability to work independently, take initiative and complete tasks to deadlines.
--Understanding and facility with CDISC/CDASH standards Demonstrated knowledge of data management and drug development process May be responsible for supervising Clinical Data Management contractors.
?? 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 preferred
Interested applicants should email resumes directly to email@example.com
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