
Clinical Data Management Professional
5 days ago
The Senior Clinical Data Manager plays a pivotal role in the data management lifecycle, overseeing various activities to ensure the integrity and quality of clinical data.
Key Responsibilities:
- Lead and assist in data management activities like validation, discrepancy review, query resolution, and reconciliation.
- Act as backup to Lead Clinical Data Manager and independently lead studies when required.
- Support Lead Clinical Data Manager or independently prepare all study-specific procedures (DMP, CCG, etc).
- Create Data Transfer Agreements when necessary.
- Participate in study kick-off meetings.
- Review Case Report Forms (CRFs) and edit checks specifications.
- Ensure deliverables meet quality standards and customer expectations.
- Lead or support the team, providing guidance and support.
- Communicate with sponsors, sites, and departments to facilitate data collection and resolve issues.
- Assist in tracking and managing projects, identifying risks, and taking corrective actions.
- May provide training on basic data management expertise to new team members.
- Perform User Acceptance Testing (UAT).
- Provide regular study status updates.
Qualifications:
- Effective communication skills in English.
- Strong leadership abilities.
- Attention to detail and accuracy is essential.
- Excellent organizational skills.
- Proven ability to manage multiple projects.
- Collaborative work style.
- Ability to work independently and meet deadlines.
- Advanced computer skills and knowledge of MS Office.
Requirements:
- Bachelor's degree in Life Sciences.
- 5-7 years of core clinical data management experience.
- Prior trial responsibility for the entire data management life-cycle.
- Ability to work flexible hours.
- Experience working on EDC systems and vendor reconciliations.
- Study start-up and close-out experience is mandatory.
- Working knowledge of SAS is preferred.
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