Associate Director, Clinical Data Management

Associate Director, Clinical Data Management

W2 Contract

Pay Rate: $95 - $110 per hour

Location: Redwood City, CA - Remote Role

Job Summary:

This position has 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 our CDM in Clinical Team meetings. The Associate Director, Clinical Data Management, will be required to 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 performs 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 ensures 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.

Duties and Responsibilities:

• Plans, coordinates, and manages CDM tasks for clinical studies.
• Participate and review CRO proposals.
• Acts as primary liaison with CROs, third-party data vendors, and 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 throughout 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.

Requirements and Qualifications:

• MS, BS/BA degree, or other suitable qualification with relevance to the field.
• 11 or more years of direct experience in designing and running early-stage or late-stage clinical trials.
• Knowledge of, and experience with, clinical 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.
• Experience from the industry is essential.

Preferred Qualifications:

• Oncology experience, especially years of tumors.
• 5 or more years' direct line management experience.

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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