Are you ready to take the lead in coordinating Clinical Data Management (CDM) deliverables on assigned clinical studies? As an Associate Director Study Data Manager, you will be a key member of the Global Study Team (GST) and the primary point of contact for the Data Management (DM) vendor. Your role will be pivotal in ensuring CDM deliverables follow standards and meet data quality, maintaining business continuity for CDM processes and standards, and upholding the integrity of the clinical database for relevant studies.
Accountabilities:
As an Associate Director Study Data Manager, you will coordinate the Clinical Data Management deliverables on assigned studies, serve as the first line of contact at the study level, and demonstrate strong leadership and project management skills. You will be responsible for overseeing day-to-day operational aspects of DM for assigned studies, identifying risks, and collaborating with the DM Vendor to mitigate these risks. You will also provide input into DM related activities associated with regulatory inspections/audits for assigned studies and oversee DM Vendor performance.
Essential Skills/Experience: University or college degree in life sciences or related subject, pharmacy, nursing or equivalent relevant degree. Solid knowledge of Clinical Data Management and experience in the Biotech/Pharma/CRO industry. Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP) and relevant regulatory requirements. Strong Project Management and Lead DM experience; Exhibits expertise in metrics analysis and reporting methodologies. Demonstrated ability to work effectively with external partners. Demonstrated experience of clinical databases, different clinical data management systems and electronic data capture (EDC). Demonstrate understanding and experience in query management process and reconciliation activities. Good communication and interpersonal skills including effective problem solving. Ability to work independently without close supervision. Excellent written and verbal communication skills. Ability to work in a global team environment. Excellent organizational and analytical skills, sound decision making skills, and high attention to detail. Desirable: Demonstrated knowledge of clinical and pharmaceutical drug development process. State of the art understanding of database structures, programming languages, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting. Demonstrated understanding of clinical data system design / development / validation and system interoperability. Demonstrates professionalism, diplomacy, mutual respect and the ability to manage/value diversity and cultural differences and promote productivity through encouragement. Experience within Sponsor and Regulatory inspections. Are you ready to be part of a team where you are empowered to follow the science and make a bigger impact on patients' lives? If your passion is science and you want to be part of a team that makes a bigger impact on patients' lives, then there's no better place to be. Apply now and join us in our mission to push the boundaries of science to deliver life-changing medicines.
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