• Evaluate and manage project budget against project milestones to ensure project profitability. Take corrective measures where necessary to keep project in line with budget and profit expectations. Track scope changes and obtain sponsor approval for change orders. Review, approve and follow-up on sponsor invoices.
• Supervisory position managing activities of Clinical Data Management staff assigned to specific sponsors. Perform Annual Employee Performance Evaluations.
• Establish appropriate project tracking using computer assisted programs and ensure timely entry of project information. Ongoing QC review of posted study documentation in study portal and in PMF for completion and audit readiness.
• Manage timelines for assigned protocol(s) and ensure that all applicable Clinical Data Management staff are aware and on target for all sponsor company deliverables. Manage sponsor expectations with regards to scope of work and deliverables. Ensure efficient cross functional handoffs.
• Escalate any potential or actual issues to supervisor, project team, and/or sponsor company in a timely manner with suggested resolution, and follow issues through to resolution.
• Ensure that Clinical Data Management staff documents initial and ongoing training as required by both Theorem and the sponsor company.
• Contribute to the development and/or revision of Clinical Data Management SOPs and related documentation.
• Present CDM function at conferences, external non-study meetings, etc. Attend Bid Defense Meetings and provide input into proposals as requested.

TRAINING & EXPERIENCE

• Medical/Nursing, Life Science/Mathematical Degree or relevant experience.
• 6+ yrs. experience, of which 2 yrs. must have been as Data Manager (or proven managerial experience); Experience leading multiple studies simultaneously.

KEY SKILLS & BEHAVIORS

• Exemplifies, delivers and expects professionalism using strong interpersonal and organizational skills.
• Keeps internal and external sponsors informed of project and/or technical issues by pro-actively communicating across teams/functions.
• Manages and directly supervises assigned clinical data management team.
• Communicates effectively through both written and verbal methods.
• Anticipates changing priorities and demands and addresses them proactively.
• Manages time effectively in order to produce quality deliverables in expected timeframe.
• Exemplifies, delivers and expects professionalism using strong interpersonal and organizational skills.