Director - Clinical Data Management

Job Description

As Director of Clinical Data Management, where you will be instrumental in shaping the Clinical Data Management (CDM) strategy for either specific therapeutic areas/indications or at a strategic level within the DM organization. You will play a crucial role in our Oncology R&D team, ensuring high-quality CDM, overseeing external partnerships, and achieving metrics for the CDM function. This role offers the opportunity to influence decision-making with cross-functional teams and foster a culture of achieving milestones with utmost customer satisfaction. Accountabilities: As Director of Clinical Data Management, you will provide leadership for assigned projects, assuming global accountability and serving as the primary point of contact at the project level. You will demonstrate operational expertise in strategic planning and the delivery of CDM objectives across projects. Responsibilities include managing vendor contracts, resource allocation, budget oversight, and ensuring optimal vendor performance for studies. Proactive risk management and issue resolution related to CDM improvements or technology are also key aspects of the role. Essential Skills / Experience: Bachelor's degree in life sciences, pharmacy, nursing, or a related field. Proven ability to manage multiple trials simultaneously and meet deadlines. Extensive experience in Clinical Data Management, ideally in both CRO and Pharma settings across multiple therapeutic areas. Strong understanding of clinical trials methodology, GCP, GDMP, and medical terminology. Proficiency in clinical standards such as SDTM or CDASH. Exceptional attention to detail and a robust analytical mindset. Outstanding interpersonal skills with demonstrated effectiveness in a global environment. Excellent written and verbal communication skills, including negotiation, collaboration, conflict management, and interpersonal interactions. Cultural awareness and ability to work effectively in diverse teams. Experience in CRO and vendor management. Leadership experience in managing teams and overseeing large Phase III trials or multiple smaller trials. Familiarity with SQL, 4GL, VBA, or R software. Experience with Regulatory Inspections and knowledge of Project Management practices. Additional Qualifications: Project Management training or certification.