Job Title

Ichnos Glenmark Innovation (IGI)IGI is an alliance between Ichnos Sciences Inc., a clinical-stage biotech company developing multispecifics™ in oncology, and its parent, Glenmark Pharmaceuticals Limited (Glenmark), with the aim to accelerate new drug discovery in cancer treatment.Our visionDaring to imagine a world where a cure is possible. Moving beyond hope, with therapies that will forever transform medicine and lives.Our missionTo co-create innovative treatment solutions that make healthier living possible.Role Overview / PurposeAccountable for Data Management deliverables from end to end and for ensuring excellence in Data Management and Data Cleaning activities, in terms of quality, timelines, and budget for clinical trials. Drive process improvement and ensure appropriate SOPs are in place to deliver high-quality data. Ensure managing and leading more junior Data Managers in terms of processes, roles, responsibilities, and personal development. Maintain overall responsibility for the quality and completion of all projects within the Data Management group.This is an exempt role and is not eligible for overtime. The good faith base salary range for NY is $160K - $170K. This is a hybrid role; 3 days in the NYC office.No relocation or immigration sponsorship is being offered at this time for this position. Candidate must be located within the tri-state area (NY,NJ,CT).Job ResponsibilitiesLeads data management activities for all Ichnos clinical studies, in-house and/or outsourced.Provides data management input into study design, protocol development, and study planning.Manages timelines for data management activities, for both outsourced and internally managed clinical studies, ensuring quality and timely delivery.Oversees and provides direction for data management activities for outsourced clinical studies and serves as an escalation point for all studies.Ensures data management activities are conducted according to applicable regulations and per protocol.Oversees and/or develops data management plans.Oversees and/or executes CRF development, database set-up activities, data validation process, UAT, medical coding, and SAE reconciliation.Oversees and/or develops eCRF completion guidelines and provides training to internal and/or CRO study team members and study site personnel.Oversees and/or develops data transfer agreements and specifications with external data vendors.Ensures consistency in data collection and processes across studies/programs, as appropriate.Oversees data review activities (data cleaning and external data review/reconciliation) and ensures completion of all activities leading to study database lock or snapshot.Tracks data management issues and ensures resolution and documentation.Communicates with relevant functions regarding study status/issue resolution.Oversees and/or executes archival of data and study-specific data management documentation.Builds a strong data management team as the portfolio grows.Oversees CRO and FSP data management deliverables to meet or exceed business objectives with respect to cost, quality, and timelines.Collaborates with relevant functions (Clinical Operations, Clinical Science, Pharmacology, Biostatistics, Regulatory Affairs, etc.) to deliver compliant datasets for regulatory submission.Ensures appropriate and consistent application of SOPs, standards, and compliance measures to deliver high-quality data packages.Develops SOPs, Work Instructions, and other process-related documents for consistency across in-house studies and delivering high-quality data packages.Desired Experience and KnowledgeEducational QualificationsMinimum BS or MSc level, with at least 10 years of experience in Clinical Data Management and a minimum of 2 years of supervisor experience is preferredExperienceDemonstrated knowledge of the Data Management aspects of the pharmaceutical, biotechnology, and/or clinical research service industries.Demonstrated knowledge of clinical research processes and methodologies, including an understanding of current GCP/ICH guidelines applicable to the conduct of clinical research.Ability to communicate effectively with internal and external parties and maintain positive and open relations.Ability to create presentations and effectively present information.Project management experience is preferred.Knowledge and Skills (Functional / Technical)Experience in contractor/CRO data management oversight.Experience in standardization of clinical collections and submission modules.Proficient knowledge of clinical data management systems and tools such as Medidata RaveTechnical experience in programming tools is preferredBehavioral AttributesAbility to work cross-culturally and across geographies.Experience in people management.A high level of self-direction and judgment related to the execution of duties and responsibilities.This is an exempt role and is not eligible for overtime. The good faith base salary range for NY is $160K - $170K. This is a hybrid role; 3 days in the NYC office.No relocation or immigration sponsorship is being offered at this time for this position. Candidate must be located within the tri-state area (NY,NJ,CT).Ichnos Sciences, Inc. & Ichnos Glenmark Innovation are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, height, weight, protected veteran status, or any other characteristic protected by law.