Senior Clinical Data Manager
Senior Clinical Data Manager
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Job Description
Job Description
Contact: Neisha Camacho/Terra Parsons
No 3rd party agencies
Senior Clinical Data Manager
Location:HomeBased
Contract
Candidates must have experience working for a small Biotech company
Job Description:
We are seeking a dynamic and innovative Senior Clinical Data Manager with a proven ability to manage the full scope of clinical trial data management from study startup through postdatabase lock. This role is ideal for a professional who thrives in a small biotech environment where wearing multiple hats and working independently is the norm. The ideal candidate will bring fresh perspectives to traditional processes offering creative solutions to enhance efficiency and effectiveness. We are looking for someone who is agile highly knowledgeable confident in their expertise and capable of providing wellreasoned professional insights.
This is a unique opportunity to bring your expertise fresh perspective and leadership skills to a small agile team making a significant impact in clinical data management.
Responsibilities:
- Serve as the primary Data Management contact and contributor for assigned clinical projects ensuring seamless continuity responsiveness and timely task completion.
- Manage endtoend data management activities including developing CRF specifications coordinating stakeholder feedback and ensuring data quality.
- Lead database build UAT maintain qualitycontrolled documentation and specify requirements for all types of edit checks (e.g. electronic manual data review).
- Oversee QC and UAT of EDC systems and modules including database and data export testing.
- Coordinate with vendors to ensure efficient and highquality electronic data receipt integration and reconciliation.
- Address and troubleshoot technical issues independently and efficiently.
- Perform SAE/AE reconciliation and oversee prelock and database lock activities.
- Collaborate effectively in vendor and internal meetings providing status updates and recommending best practices.
Requirements:
- Bachelors degree in a clinical or scientific discipline with 9 years of direct clinical data management experience in pharmaceutical academic or CRO settings.
- Demonstrated ability to work independently in a fastpaced environment with minimal supervision.
- Expertise in EDC systems such as Medidata Rave InForm or Medrio.
- Strong track record of handson clinical data management experience including leadership capabilities and strategic thinking.
- Proficiency in CDISC/SDTM standards and familiarity with SAS SQL or other programming tools.
- Indepth understanding of clinical data coding systems (e.g. MedDRA WHODrug) and Good Clinical Data Management Practices.
- Exceptional organizational time management and communication skills.
- Ability to critically evaluate and rethink traditional processes implementing innovative and effective solutions.
- Collaborative and confident with the ability to liaise across all levels of the organization and external partners etc.
Required Experience:
Manager
Employment Type
Contract
