Associate Director, Clinical Data Management
About The Position
As the Associate Director, Clinical Data Management, you will play a key role in the day-to-day management of Clinical Data Management (CDM) activities. Including timely and professional management of clinical trial data for all relevant phases. Represents the data management function in Clinical Team meetings. This person will collaborate closely with other functional leaders to ensure clinical trial success. Defines project-level data management strategy. Identifies requirements for capturing and processing of clinical data ensuring accuracy, consistency, and completeness. Manage external vendors providing clinical data. Manages and/or perform data management tasks according to strict quality standards including SAE reconciliation, third party vendor data reconciliation, medical coding processing, protocol deviation collection, query management to identify errors and inconsistencies in clinical data and ensure their resolution. Provides CDM oversight of outsourced and partner-resourced clinical trials including scoping trials, project management, relationship management, approval of deliverables, and coordination of internal reviewers. As the team grows, this role will be responsible for identifying and developing data management resources. Plans, coordinates, and manages CDM tasks for clinical studies. Participate and review CRO proposals. Acts as primary liaison with CROs, third party data vendors, EDC vendors. Reviews clinical protocols and cross functional plans. Serves as primary reviewer or author of case report forms (CRFs) and CRF completion guidelines. Oversees and participates in all aspects of EDC database development, testing, maintenance, and lock/unlock. Ensures Data Management Plans are followed through the course of the studies. Sets and manages Data Management project timelines. Provides comprehensive status updates to project team members. Address data issues identified by cross-functional team members, accountable for external data vendor documentation, management, and reconciliation. Assist in defining and creating data listings, summary table validation, data specifications, and process data transfers in preparation for statistical review and data management audit. Implements data standardization and maintains data model across projects. Direct management and mentoring responsibilities for internal data management team members. Lead department initiatives e.g., development of SOPs. Review abstracts, manuscripts, and presentations for accurate representation of clinical data. Collaborates on other duties as assigned.
Requirements
- Minimum of 12 years of relevant medical device clinical experience.
- Knowledge of FDA guidelines and other relevant geographical regulations.
- Ability to travel and work onsite in Santa Cruz as needed, ideally quarterly.
- Ability to work outside the Monday-Friday, 9am-5pm schedule, especially to account for travel and different geographies.
- MS, BS/BA with 12+ years of related experience or other suitable qualification with relevance to the field.
- Direct experience of designing and running early-stage and pivotal medical device clinical trials.
- Knowledge of, and experience with databases, standards, medical terminology, medical coding dictionaries, quality control processes, and auditing procedures.
- Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
- A demonstrable record of strong leadership and teamwork.
- Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high energy environment.
- Excellent written and verbal communication skills.
- Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute on goals as a member of an interdisciplinary team is extremely important.
Responsibilities
- Manage external vendors providing clinical data.
- Manage and/or perform data management tasks according to strict quality standards including SAE reconciliation, third party vendor data reconciliation, medical coding processing, protocol deviation collection, query management to identify errors and inconsistencies in clinical data and ensure their resolution.
- Provides CDM oversight of outsourced and partner-resourced clinical trials including scoping trials, project management, relationship management, approval of deliverables, and coordination of internal reviewers.
- Plans, coordinates, and manages CDM tasks for clinical studies.
- Participate and review CRO proposals.
- Acts as primary liaison with CROs, third party data vendors, EDC vendors.
- Reviews clinical protocols and cross functional plans.
- Serves as primary reviewer or author of case report forms (CRFs) and CRF completion guidelines.
- Oversees and participates in all aspects of EDC database development, testing, maintenance, and lock/unlock.
- Ensures Data Management Plans are followed through the course of the studies.
- Sets and manages Data Management project timelines.
- Provides comprehensive status updates to project team members.
- Address data issues identified by cross-functional team members, accountable for external data vendor documentation, management, and reconciliation.
- Assist in defining and creating data listings, summary table validation, data specifications, and process data transfers in preparation for statistical review and data management audit.
- Implements data standardization and maintains data model across projects.
- Direct management and mentoring responsibilities for internal data management team members.
- Lead department initiatives e.g., development of SOPs.
- Review abstracts, manuscripts, and presentations for accurate representation of clinical data.
- Collaborates on other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
