Principal Clinical Data Manager

Job Description

As a Principal Clinical Data Manager, your role will be to support the Directors of various groups in a fully outsourced model.

You will be hands-on while also bringing in your wealth of experience. Ideally, candidates should have a experience in Clinical Data Management with 8+ years of experience.

We welcome candidates from both Sponsor side (small or large pharma) and from a CRO. If you're from a CRO, you should have a good understanding of what it takes to manage a CRO even without prior experience in doing so.

You should be a critical thinker, not just a 'yes person', and be willing to ask questions when needed and bring your ideas to the table.

Therapeutic Area knowledge is not specific, however, Infectious Disease would be ideal. Experience with Medidata Rave is required.

Here’s What You’ll Do :

• Perform data management oversight activities for large, late phase trials in support of clinical studies; oversee the activities of CRO DM counterparts to ensure adherence to scope of work and service agreements, and to ensure deliverables are met in accordance to quality
• Collaborate with clinical study teams and vendors to ensure project deliverables are met, including data acquisition, quality data review and reporting in compliance with GCP, SOPs and regulatory requirements
• Participate in the development of all Data Management documentation including the electronic Diary Specifications CRF, Data Management Plan, CRF Completion Guidelines, Data Validation Specification, Data Transfer Specifications, etc.
• Manage clinical trial data through review, cleaning, auditing, validation procedures and ensure data handling compliance with regulatory requirements, especially as it pertains to electronic Diary data collection and handling
• Performs oversight of third party clinical data vendors (; electronic diary, clinical laboratory)
• Review data analysis listings and report on performance and quality; review clinical data within studies and across for trend analysis
• Perform thorough development testing of the electronic Diary and eCRF prior to deployment, inclusive of User Acceptance Test (UAT) Plans, Test Scripts and execute testing applicable
• Collaborate with clinical study team members and lead the Cross-Functional Data Review for clinical studies
• Responsible for the review and compliance of the Trial Master file (TMF). Ensure that all required documentation is filed in a timely manner in agreement with the Study TMF Index Plan.

Here’s What You’ll Bring to the Table :

• Bachelor’s Degree in a science-based subject expertise.
• At least 8 years of clinical data management experience in industry, with experience across indications and EDC and electronic Diary platforms
• Late phase development, inspection readiness and electronic submissions experience
• Multi-faceted experience devising plans for operational challenges such as cohort level analysis, preparing cohorts for data review in dose escalation, multiple vendor oversight, electronic data transfer coordination
• Cross Collaboration proficiency with other functions such as Clinical Development, Clinical Operations, Biostatistics, Statistical Programming, and Pharmacovigilance
• Thorough command of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
• Outstanding verbal and written communication skills, in addition to excellent organizational skills
• Creative, capable problem-solver

Hard Skills

• 8+ years of Clinical Data Management experience
• Experience with Medidata Rave
• Understanding of managing a CRO (if coming from a CRO)
• Infectious Disease knowledge (ideal but not required)

Job Type

This is a contract position with a duration of 6 Month(s).

Work Site

This is a fully remote position.

Work Environment

Our work environment is 100% remote. We operate at a fast pace but maintain a strong collaborative spirit. The right fit for our team is someone who is eager to actively participate and contribute, rather than just keeping their head down.