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Manager, Clinical Data Management

Employer
Nektar Therapeutics
Location
San Francisco, CA, United States
Start date
Jul 27, 2021

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Discipline
Clinical, Clinical Data
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

Job Details

Position Overview

Nektar has an exciting opportunity for a Manager Clinical Data Management to join the team.

Summary:

The Manager, Clinical Data Management is responsible for ensuring study launch, conduct, and closeout are performed according to Nektar's quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations. The assigned clinical trial(s) may be high complexity or high risk. Duties include serving as the primary data management liaison with vendors and senior management. This position will manage essential duties and responsibilities as independently as possible, with guidance and oversight provided by senior data management when needed. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Responsibilities:

• Maintain effective communication with vendors and Nektar's internal project team through oral and written correspondence, project status and progress reports. • Manage the planning, implementation and overall direction of executing clinical trial data management activities including protocol review, electronic system configuration, Case Report Form (CRF/eCRF) design, database development, validation programming, and discrepancy management. • Prepare information for internal meetings. • Maintain and evaluate project progress by managing timelines and other tracking/analysis tools. • Design, produce and distribute standard and customized status, resourcing, and tracking reports as well as functional area plans, to appropriate team members and senior management. • Work on problems of a diverse scope. Exercise judgment in managing tasks within generally defined practices and policies in selecting methods and techniques to track and manage timelines, risk, and data quality. • Manages the cross-functional collaboration, development, and maintenance of the components of the study Data Management Plan (DMP) and data management deliverables including the Case Report Form (CRF), CRF completion guidelines, SAS annotated CRFs, data handling plan, data review plan, edit check specifications, data transfer specifications, data quality plan, etc. • Manage the interaction with data management vendors to ensure that data management tasks remain on target according to project timelines. • Proactively organize on-going data review throughout the conduct of the study to ensure timely and appropriate identification of errors and discrepancies. • Facilitate the correction of errors and discrepancies through the site query process, document permanent data issues, communicate issues with team members, and deliver a quality locked database for analysis. • Provide input to the data management study budget and responsible for managing assigned vendor budget(s). • Lead new data management initiatives such as establishing capacity for electronic data capture and clinical outcome assessments. • Conduct CRO data management function inspections and audits. • Contribute to the development and implementation of departmental policies, standards and process improvement initiatives. • May mentor and develop junior data management staff.

Requirements:

A bachelor's degree in clinical, biological or mathematical sciences, nursing degree, or equivalent related field education and experience is required. A master's degree is preferred. A minimum of 8 years actively managing clinical research projects in collaboration with other functional areas with at least 2 years successfully managing CROs is CROs is preferred. Previous supervisory, oncology and/or central nervous system experience is preferred. A thorough knowledge of FDA regulations, drug development and clinical monitoring procedures is required. Demonstrated problem solving abilities and strong presentation, documentation, organizational, and interpersonal skills as well as a team-oriented approach are required. Excellent written and verbal communication skills are required. Demonstrated proficiency with ICH, GCDMP, and GCP is required. Fluent English is required. Proficient computer skills using Word, Excel, PowerPoint, MS Project, email and the internet are required. Demonstrated self-starter with the ability to mentor and handle multiple tasks to meet deadlines while delivering high quality work in a dynamic work environment. Must possess excellent project management skills and have demonstrated ability to develop data management processes and training. Previous people management experience is preferred.

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.

Company

Nektar Therapeutics is a research-based development stage biopharmaceutical company that discovers and develops innovative medicines in areas of high unmet medical need. Our R&D pipeline of new investigational drugs includes treatments for cancer and auto-immune disease. We leverage Nektar's proprietary and proven chemistry platform in the discovery and design of our new drug candidates. Our success is rooted in four key elements: our track record reflected by a portfolio of successful approved medicines which emanated from our chemistry platform and are made available globally by our pharmaceutical partners, our unique research and development pipeline of new investigational medicines in cancer and immunology, our proprietary and proven science and technology approach that fuels our discovery efforts and our team of dedicated scientists, clinicians and employees focused on bringing new medicines to patients with debilitating diseases.

Stock Symbol: NKTR

Stock Exchange: NASDAQ

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Company info
Website
Phone
415-482-5300
Location
455 Mission Bay Blvd South
San Francisco
California
94158
United States

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