Associate Director / Director, Data Management

Job Description

Job Description

Salary : $160,000 - $230,000

About Codera

Codera is a Tang Capital company that provides in-house end-to-end drug development for its portfolio companies. Founded in 2002, Tang Capital is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products.

Position Summary

The Director or Associate Director, Data Management supports the Data Management (DM) department and all clinical development programs. This individual is responsible for Electronic Data Capture (EDC) vendor oversight, project timeline management, clinical database setup through closeout, creation of data management documents, data metrics reporting, and data cleaning activities.

The ideal candidate is open to starting on a consulting basis, with the potential to transition into a full-time, permanent position.

Essential Duties and Responsibilities

Act as the data management lead for one or more clinical studies including responsibility for all data management and back-end activities from database start-up through database lock

Establish and oversee partnerships with DM vendors and other external partners

Ensure clinical databases and external data files are designed in a standard, accurate, complete, and consistent format to produce datasets that are conducive to analysis and regulatory submission

Oversee data management vendors with respect to key performance indicators, metrics, program level deliverables, and timelines

Review and provide feedback to the clinical team on study documents, including clinical monitoring plans, statistical analysis plans and vendor specifications

Review protocols for all data management activities to ensure data is properly captured via CRF design and data requirements

Coordinate and participate in the review of clinical data, tables / listings / figures (TLF) analysis, and patient profiles for data consistency and accuracy

Ensure that all clinical trials have complete and accurate data and supporting documentation for regulatory submission and data analysis, including raw datasets and annotated CRFs

Ensure data management project documentation is in an audit-ready format

Oversee the building, validation, and maintenance of clinical trial databases in accordance with ICH / GCP guidelines and current regulatory requirements

Oversee the generation of key documents such as data validation specifications, manual data review guidelines, data management plans, data cut plans, CRF completion guidelines, data access plan, data transfer agreements, etc.

Work closely with statistics and programming to ensure high-quality data output including data cleaning / validation, SAS listings review, TLF dry runs, etc.

Develop, track, analyze, and report internal data management performance metrics

Lead computer system development initiatives including database integration, data sharing, access, and storage

Support the setup of other systems such as the safety database and IRT

Contribute to budget / resource planning, re-forecasting and program milestones

Provide leadership, training, and support to data managers

Communicate and escalate project issues involving processes, timelines, resourcing, performance, etc. and establish appropriate courses of action with senior management

Assist in the preparation and support of clinical documentation for IND and NDA submissions as appropriate

Assist with directing the activities of the data management team to complete project deliverables on schedule and per quality standards and requirements from study start-up through archival

Assist with the development of SOPs and specific quality processes and procedures for data management

Ensure data management activities are conducted in accordance with GCP, internal SOPs, and all regulatory requirements

Assist with departmental performance evaluations, goal setting, career development, and growth

Ensure all study specific training is kept up to date and documented for the department

Qualifications

Bachelors Degree required

Minimum 10 years of clinical data management experience in biotechnology or pharmaceutical industry required

Advanced knowledge of data management processes and systems

Advanced knowledge of setting up Clinical Databases in Medidata Rave

Solid understanding of clinical drug development processes

Must be self-motivated, well-organized, detail-oriented, and have excellent written and verbal communication skills

Possess a willingness and ability to work hands-on and with a sense of urgency, in a fast-paced, entrepreneurial environment

Must be highly resourceful and adaptable to effectively support multiple competing demands and changing priorities

Excellent organizational skills with the ability to manage staff, projects, resources, timelines, and budgets

Travel requirements include travel domestically and / or internationally up to 20%

Codera is an equal opportunity employer. Codera is an E-verify employer.