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Associate Director of Clinical Data Management

Terns Pharmaceuticals

This is a Full-time position in Menlo Park, CA posted June 30, 2021.

Associate Director, Clinical Data Management
Location: Foster City, CA
Type: Full Time Min.

Experience: Experienced
Position Overview
We are seeking a talented, experienced, and highly motivated individual to join the development operations team at Terns Pharmaceuticals and help advance the Terns portfolio of small molecule drug candidates for the treatment of non-alcoholic steatohepatitis (NASH).

The Associate Director, Data Management, is responsible for leading the data management functions and coordinating functions related to the planning, execution, collection, and cleaning of clinical data.

This position has oversight of activities leading to the final delivery of clean clinical data for the purpose of clinical study reports, publications, and regulatory submissions.

In addition, this position has leadership role responsibilities to proactively develop plans for the utilization of EDC system and other clinical data applications that allow for internal control of clinical databases.

This position requires assessment of resources and therefore, may have direct supervisory responsibilities for internal staff or external consultants or oversight of FSP resources.

This position will take a leadership role in defining Sponsor processes and procedures for maintaining clinical data and the associated QA/QC documentation.

This individual should have a desire to work in a dynamic environment in partnership with cross-functional team members, with a culture of collaboration.
Responsibilities
To perform this job successfully an individual must be able to perform each essential function satisfactorily.

Develop and implement strategic vision for data management (DM) Responsible for managing, planning and coordinating the activities for Data Management Responsible for ensuring the data collected meets the requirements of the study objective and company quality standards.

Ensure that the Data Management strategy and processes are aligned with business objectives and complies with FDA requirements.

Contribute to development of outsourcing strategies and relationships with outsourcing partner and play a key role in identification of quality DM partners including participating in the review of contracts and Master Services Agreements Work closely with CROs to prepare and ensure proper execution of data management plans; manage data management projects from beginning to end.

Coordinate the transfer of clinical data between all vendors participating in a clinical study.

Provide oversight on quality database design, validation, and deployment to ensure quality and efficiencies through data and process standardization.

Work closely with study management team in planning and execution of DM activities regarding clinical studies.

Coordinate with biostatisticians, data managers, CRAs, programmers, etc., to expedite and assure the flow of data between study sites, the data management group.

Prepare and distribute or facilitate distribution of periodic reports of study status including, CRF completion status, missing pages, query aging, etc.

Participate in cross functional team meetings as requested.

Coordinate with SAS programmers to create and validate database design and edit check specifications.

Communicate with all departments regarding project statuses/issues, provide ongoing feedback on data management workflows to increase efficiency Ensure coding of safety data is accurate using industry standard coding conventions.

Oversee interactions with central clinical laboratories on collection, transmittal and transfer of study specific data.

Develop and update SOP’s associated with the data collection, handling and review processes to meet regulatory compliance and operational needs.

Assist with the validation of the statistical output for final reports.

Audit potential data management vendors, as appropriate.

Assist in design of case report forms (CRFs), DMPs, and CCGs for clinical studies.

Take a leadership role in the review and query of clinical data.

This includes the critical review of data-populated tables, figures, and listings as part of the database clean-up and prior to database lock.

Provide technical direction to facilitate the adoption and use of technologies for DM and trial management.

Assure regulatory compliance of vendors and investigational sites with company SOPs, FDA and ICH guidelines, and other applicable regulations and guidelines.

Mentor clinical team members by resolving problem and providing DM guidance.

Manage multiple and varied tasks, prioritize workload with attention to detail.

May manage the clinical data managers within the organization if additional internal resource needs are required.

Other duties as assigned.
Requirements
Requires a Bachelor’s degree.

Minimum of 8 years’ experience in a clinical research data handling environment with relevant practical experience in protocol review/CRF design, clinical study databases and data management Direct report experience, preferred.

Knowledge of industry standards, such as the ICH guidelines, CDASH, 21 CFR Part 11, and FDA guidelines.

Experience with SAS.

Excellent time management, ability to coordinate workload and meet established deadlines.

Strong verbal and written communication skills are essential.

Excellent organization and multi-tasking skills.

Exceptional interpersonal skills and problem solving capabilities.

Ability to work effectively across a matrix organization.

Ability to work independently and prioritize with minimal daily instruction.

Ability to think strategically in order to improve current processes.

This position can be office based or fully remote in the US.
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