Associate Director, Clinical Data Management

Location
San Francisco, CA, United States
Posted
May 04, 2018
Ref
3202-525-2018
Discipline
Clinical, Clinical Data
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Summary:

Manages all aspects of data management for assigned project(s). This includes CRF/eCRF design, database development, validation programming, discrepancy management, and database release. Works with senior management within Data Management, Biostatistics, Clinical Operations, and Regulatory teams to establish and approve data collection methods in accordance with the clinical programs. Interacts with various inside/outside groups like Contract Research Organizations (CROs) and other service providers to assure quality within the data management life cycle. May select, develop, and evaluate personnel to ensure the efficient operation of the function. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Responsibilities:

Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Demonstrated ability to work on complex technical problems providing innovative solutions. Exercises judgments within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Ensures budgets, schedules and performance requirements are met. Directs the development, management, and execution of the study Data Management Plan (DMP) which includes the data collection strategy, Case Report Form (CRF), CRF completion guidelines, SAS annotated CRFs, data handling plan, data entry review guidelines, edit check specifications, data transfer specifications, and database audit plan. Define programming and reporting standards, conventions and rules. Implement and maintain a regulatory-compliant process for acquisition, archive, and interchange of clinical study data. Provide oversight across multiple trials to ensure consistency in data collection, transmittal, and reporting as well as security and integrity across clinical data collection systems. Works with clinical, biostatistics, and regulatory teams to design and develop study documents including Clinical Protocol, Case Report Forms (CRFs) and Statistical Analysis Plan (SAP). Directs the interaction with contract data management groups to ensure that data management tasks remain on target according to project timelines. Proactively organizes on-going data review throughout the conduct of the study to ensure timely and appropriate identification of errors and discrepancies by working with a contract data management group. Responsible for the correction of errors and discrepancies through the site query process, for documenting permanent data issues, routinely communicating issues with team members and the delivery of a quality locked database for analysis. Leads new data management initiatives such as establishing capacity for electronic data capture. Conducts CROs data management function inspections and audits. Contributes to the development and implementation of departmental policies, standards and process improvement initiatives. May mentor and develop junior clinical data management staff.

Requirements:

A minimum of a Bachelor's degree in clinical, biological, mathematical sciences or related field, or nursing qualification is required. An advanced degree is preferred. Equivalent experience may be accepted. A minimum 10 years pharmaceutical development experience with at least 4 years managing CROs is required. Must be able to demonstrate extensive experience in the design of clinical studies. A minimum of 8 years previous management experience is preferred. Must have demonstrated problem solving abilities and strong organizational skills. Excellent written and verbal communication skills are required. Experience and understanding of ICH, and GCP is required.
Must be a demonstrated self-starter and team player with strong interpersonal skills. Must possess excellent project management skills. Advanced knowledge of Data Management processes and systems. Solid understanding of clinical drug development processes is preferred. Ability to develop data management processes and training is preferred. Previous people management experience is preferred. Effective problem solving skills. Must have strong computer system validation skills with a proficiency in Microsoft applications (Word, XL), programming languages/tools (J-Review, SpotFire, SAS, Java, C++), and relational databases (SQL, PL/SQL, etc.).

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.