Atorus Research
Associate Director, Clinical Data Management
Atorus Research, Conshohocken, Pennsylvania, United States
Overview
Associate Director, Clinical Data Management. Full-time, partially onsite in Conshohocken, PA 19428. The Associate Director of Clinical Data Management will lead and oversee a team within the Clinical Data Management department, ensuring the successful execution and completion of clinical data management deliverables for assigned clinical trials or programs. This role is responsible for driving data management strategy and ensuring the effective development and execution of data solutions to support large, complex clinical trials or programs consisting of multiple clinical trials. This role is also responsible for DM vendor management, contract reviews and relationships to ensure vendor tasks and responsibilities are in compliance with standard operating procedures and regulatory agency guidelines. The Associate Director will also lead internal data management-related study/program status communication, escalation and stakeholder management. Responsibilities
Leadership & Oversight: Provide leadership, mentoring and oversight to the clinical data management study/program team, ensuring alignment with strategic goals. Data Management Strategy: Develop and implement data management strategies to support clinical trials, ensuring high-quality data from database build through data cleaning and review. Represent CDM from a strategic planning and execution capacity in program level and study team meetings. Understand and influence CDM resourcing strategies to meet the current program/study needs. Cross-Functional Collaboration: Serve as the senior Clinical Data Management representative on multi-disciplinary study or program teams, providing guidance, direction, and oversight. Ensure cross functional alignment on clinical data management activities. Innovation & Efficiency: Oversee the implementation of innovative solutions to streamline data management operations. Lead/Sponsor CDM department-level improvement initiatives. Project Management: Lead and manage key data management activities, leveraging project management methodologies to ensure timely delivery of high-quality data. Develop and ensure that deep knowledge of internal, external and regulatory requirements/expectations are understood, well communicated and applied to data deliverables. Stakeholder Management: Manage relationships and alignment with key cross-functional stakeholders and functional leadership, addressing escalations as needed. Vendor Oversight: Oversee the effectiveness of data management vendors, leveraging governance and escalation pathways to ensure delivery meets expectations. Transparency & Alignment: Ensure cross-functional alignment and transparency regarding study/program data management deliverables, priorities, timelines, risks, and issues. Meeting Participation: Present updates at key meetings, such as Project Review meetings. Performs any and all other tasks and activities as requested. Qualifications
Bachelors or Masters in Life Sciences, Statistics, Informatics, Computer Sciences, related fields, or equivalent experience. At least 12 years of directly relevant work experience. Experience as Clinical Data Manager and relevant roles in the pharmaceutical/biotechnology industry, or CRO. Demonstrated leadership overseeing DM technical responsibilities and systems to execute DM implementation strategy. Experience delegating work to more junior-level data management staff, providing direction, guidance, feedback, mentoring, and coaching, as necessary. Experience negotiating solutions with cross functional team members and stakeholders with consideration to priorities, regulations, quality, and budget. Strong communication skills with experience providing updates, issues and proposed solutions to senior-level stakeholders. Experience overseeing and managing relationships with CROs and other data management-related vendors. Understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice. Experience in the implementation and management of data review principles and strategies. Experience in Medidata RAVE, data visualization tools and supporting systems. Understands the scope and focus of Phase 1-4 clinical studies and has a proven ability to perform core Data Management tasks. Excellent project management skills and a proven ability to multitask. Attention to detail and the ability to work independently and/ or within a multi-disciplinary team, as well as with external partners and vendors. Experience and understanding of the Oncology therapeutic area and with Phase III and/or Pivotal studies are preferred. Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications. Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems.
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Associate Director, Clinical Data Management. Full-time, partially onsite in Conshohocken, PA 19428. The Associate Director of Clinical Data Management will lead and oversee a team within the Clinical Data Management department, ensuring the successful execution and completion of clinical data management deliverables for assigned clinical trials or programs. This role is responsible for driving data management strategy and ensuring the effective development and execution of data solutions to support large, complex clinical trials or programs consisting of multiple clinical trials. This role is also responsible for DM vendor management, contract reviews and relationships to ensure vendor tasks and responsibilities are in compliance with standard operating procedures and regulatory agency guidelines. The Associate Director will also lead internal data management-related study/program status communication, escalation and stakeholder management. Responsibilities
Leadership & Oversight: Provide leadership, mentoring and oversight to the clinical data management study/program team, ensuring alignment with strategic goals. Data Management Strategy: Develop and implement data management strategies to support clinical trials, ensuring high-quality data from database build through data cleaning and review. Represent CDM from a strategic planning and execution capacity in program level and study team meetings. Understand and influence CDM resourcing strategies to meet the current program/study needs. Cross-Functional Collaboration: Serve as the senior Clinical Data Management representative on multi-disciplinary study or program teams, providing guidance, direction, and oversight. Ensure cross functional alignment on clinical data management activities. Innovation & Efficiency: Oversee the implementation of innovative solutions to streamline data management operations. Lead/Sponsor CDM department-level improvement initiatives. Project Management: Lead and manage key data management activities, leveraging project management methodologies to ensure timely delivery of high-quality data. Develop and ensure that deep knowledge of internal, external and regulatory requirements/expectations are understood, well communicated and applied to data deliverables. Stakeholder Management: Manage relationships and alignment with key cross-functional stakeholders and functional leadership, addressing escalations as needed. Vendor Oversight: Oversee the effectiveness of data management vendors, leveraging governance and escalation pathways to ensure delivery meets expectations. Transparency & Alignment: Ensure cross-functional alignment and transparency regarding study/program data management deliverables, priorities, timelines, risks, and issues. Meeting Participation: Present updates at key meetings, such as Project Review meetings. Performs any and all other tasks and activities as requested. Qualifications
Bachelors or Masters in Life Sciences, Statistics, Informatics, Computer Sciences, related fields, or equivalent experience. At least 12 years of directly relevant work experience. Experience as Clinical Data Manager and relevant roles in the pharmaceutical/biotechnology industry, or CRO. Demonstrated leadership overseeing DM technical responsibilities and systems to execute DM implementation strategy. Experience delegating work to more junior-level data management staff, providing direction, guidance, feedback, mentoring, and coaching, as necessary. Experience negotiating solutions with cross functional team members and stakeholders with consideration to priorities, regulations, quality, and budget. Strong communication skills with experience providing updates, issues and proposed solutions to senior-level stakeholders. Experience overseeing and managing relationships with CROs and other data management-related vendors. Understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice. Experience in the implementation and management of data review principles and strategies. Experience in Medidata RAVE, data visualization tools and supporting systems. Understands the scope and focus of Phase 1-4 clinical studies and has a proven ability to perform core Data Management tasks. Excellent project management skills and a proven ability to multitask. Attention to detail and the ability to work independently and/ or within a multi-disciplinary team, as well as with external partners and vendors. Experience and understanding of the Oncology therapeutic area and with Phase III and/or Pivotal studies are preferred. Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications. Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems.
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