Clinical Data Management Lead

About the job

Are you a project manager obsessed with data accuracy? Do you feel thrilled by the opportunity to work with game-changing solutions? This is the right opportunity for you. From building the database to locking it down, IQVIA provides a data management model where EDC and third party data are acquired and cleaned in real-time – providing faster decision-making, better outcomes and alerting sites and patients to issues.

 

 

The Team and the Scope

 

As Project Lead accountable for delivery and management of accurate clinical data, you will be an essential part of Clinical Data Management (CDM) team. Our clinical data management teams produce results that are verified at the source, delivering the transparency, integrity, accountability, speed, and accuracy the customers need. The right data management helps the customers see the insights beyond the numbers. The final goal of your activity is the supervision of end-to-end delivery of data management services for single/multi-service projects with minimal guidance, ensuring quality deliverables on time and within budget, to customer satisfaction.

 

As an influential leader, you will give inputs to the team for project planning, execution, and close-out, but also financial management, communications, and milestone deliverables.

Are you ready to help us in driving the healthcare forward?

 

Core Competencies

 

§ Stakeholders & Shareholders Management:

 

• Serve as primary point of contact for customer on data management deliverables

• With guidance, provide input for and perform direct negotiations with customer, e.g., timelines, financial, process, resources

• Ensure open communications with customer's stakeholders and IQVIA management to handle and meet contractual obligations

•Your communication is clear and

 

 

 

§ Project Management:

 

•You know when and how to apply a waterfall method or rely on a lean one.

•You are determined to succeed and your personal charisma and hands-on technical savvy are the key factors of your influence

•Your accountability stands out

•With guidance, ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW)

• Manage budget

• Review financial reports on a monthly basis and participate in project reviews as requested

• Identify out of scope tasks and track change orders to completion

• With guidance, participate in and support RFP process (review RFP documents, pricing, attend bid defense)

 

§ Clinical Trials and Data Management:

 

•You have a solid experience in Clinical Trials, therefore you are able to easily identify actors and potential risk factors;

•You have the proven expertise in liaising the data tech savvy with highly regulated procedures (SOP, GCP, EMA and local drug agencies' laws)

• With guidance, create and/or review and sign-off on all data management plan (DMP) documents

• Implement proactive quality management plan. Identify any service and quality issues with agreed upon specifications per the DMP and contract/SOW and work with functional manager(s) to resolve

• With guidance, track service performance and provide leadership to identify root causes of issues and implement remedial actions

• Continuously look for opportunities to improve efficiency of tasks and quality of deliverables

• Identify compliance issues and work with functional manager(s) to ensure timely follow-up and resolution

• With guidance, maintain internal tracking databases and systems

• Supervise Data Operations Coordinator (DOC) and/or Data Operations team members to ensure milestones meet timelines and quality deliverables

• Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders

• With minimal guidance, support DM service delivery with comprehensive DM process and technical expertise in executing projects.

• Serve as the escalation point for unresolved data issues

 

 

Qualifications

 

• Bachelor's Degree Health, clinical, biological or mathematical sciences, or related field
• 3 years direct Data Management experience, including 1 or more years as a project lead. Equivalent combination of education, training and experience.
• Previous experience and proven competence in managing study delivery through full DM life-cycle .
• Demonstrated data management skills and thorough knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology).

 

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

Intrigued? Feel free to contact the job poster:

eros.reale@iqvia.com

EMEA Talent Acquistion at IQVIA

Passionate about #braveminds to drive #clinicaltrials forward!