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Director, Clinical Data Management - Operations

Onyx Pharmaceuticals, Inc.

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Location:
South San Francisco, CA
Posted Date:
7/9/2014
Position Type:
Full time
Job Code:
4560809HHL
Salary:
Competitive
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Clinical Data Management,

Job Description

Based in South San Francisco, California, Onyx Pharmaceuticals is an Amgen subsidiary, engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer. At Onyx, our success begins with our employees. The progress we have made as a company reflects the talents of the individuals who have come together to develop possible new therapeutics for treating cancer. Onyx is seeking talented and dedicated individuals of the highest caliber who are passionate about the pharmaceutical industry and driven to change the way cancer is treated.
Based in South San Francisco, California, Onyx Pharmaceuticals is an Amgen subsidiary, engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer. At Onyx, our success begins with our employees. The progress we have made as a company reflects the talents of the individuals who have come together to develop possible new therapeutics for treating cancer. Onyx is seeking talented and dedicated individuals of the highest caliber who are passionate about the pharmaceutical industry and driven to change the way cancer is treated.

We are looking to fill the position of Director, Clinical Data Management

This role is responsible for the planning, implementation and overall direction of clinical trial data management activities including CRF design, database development, validation programming, discrepancy management, database release and oversight of external business partners, including technology vendors and CROs and management of external electronic data sources. This position interacts with Biostatistics, SAS programming, Clinical Science, Clinical Operation, Safety personnel and QA on a daily basis to ensure compliance with protocols, SOPs and overall clinical objectives. Oversee metrics development and implementation for Clinical development.

Primary duties of this role include:
* Recruits, trains and manages employees and consultants with area of responsibility;  Sets training standards
* Contributes to technical infrastructure of the Clinical Data Management and process improvement
* Provides leadership in facilitating knowledge sharing and creation, leading to best practice and improved quality and processes in clinical programming.
* Oversees all Clinical Data Management support activities for clinical programs in line with timely and accurate data requisition, integration, analysis and interpretation of results
* Oversees the process to identify, evaluate and select Contract Research Organizations (CRO). Responsible for contract negotiation and sign-off
* Implements documentation and archival standards of Clinical Data Management deliverables including DM systems, databases, programs, and specifications
* Determines major reporting deliverables and milestones for regulatory submissions
* Working with IT, ensures that local IT infrastructure meets Biometrics needs and global standards
* Represent CDM in Study Execution Team(SET) meetings; establishes and negotiates timelines with internal and external team members for completion of activities for a group of projects
* Responsible for budget and resource planning across several projects
* Identifies areas of deficiency requiring SOPs or guidelines and develop and execute a plan to rectify
* Manages group of internal data managers, consultant data managers. Mentors and develops direct employees
* May provide training of the CRF completion guidelines, EDC system at Investigators' meeting and to internal and external project members as needed
* Represents the function in external professional initiates and organization to identify industry best practices
* Manages group of internal data managers, consultant data managers. Mentors and develops direct employees.
* May require travel up to 15% of the time
* Other Duties as assigned

* Bachelors degree

* Bachelor in Computer Sciences, Mathematics, Life Sciences with 12+ years of data management experience in the pharmaceutical or biotechnology industry, including 8+ years of staff management experience OR MA/MS with 10+ years of experience, including 8+ years of people management experience.
* 2+ years in oncology
* Experience with an EDC system
* Track record in performing and managing a functional team to support multiple projects and Biometrics initiatives.
* Expert skills in a pharmaceutical or CRO working in a FDA regulated environment
* Good working knowledge of ICH, FDA, and GCP regulations and guidelines; Strong well-rounded technical skill including CDASH, SAS, SDTM and CDISC
* Demonstrated working knowledge of data management systems and scientific principles
* Solid knowledge of clinical trial process and regulatory requirements
* Understands and applies data management technology, software languages and computer systems
* Demonstrate knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations
* Skilled in multiple computer-based tools, in addition to software programs such as Word, PowerPoint, Excel, etc.
* Ability to link multiple and varied concepts to develop new and workable ideas
* Scientific background and understanding of clinical trials, pharmaceutical operations, and regulatory compliance
* Supporting DMC; working directly with DMC; working with steering committees
* Knowledge of pharmacokinetics and pharmacodynamics a plus
* Dynamic, self starter with strong influential skills
* Strong organizational, communication, negotiation and interpersonal skills
* Ability to work independently and understand current material
* Attentive to detail, flexible, open to suggestions, and possess good communication
* Strong time management and organizational skills
* Ability to relate and work with a wide range of people to achieve
* Excellent verbal/written and interpersonal skills needed for working successfully in a cross-functional team environment; communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email
* Ability to act independently to determine methods and procedures on new assignments
* Passionate about helping others achieve their maximum potential
* Ability to adapt quickly to change
* Demonstrated ability to create strong, collaborative working relationships and encourage creative solutions by effectively working through conflicts
* Ability to think ahead and plan both short term and long term goals for the company
* Ability to manage multiple tasks while meeting project milestones

*LI-TK1

Amgen is an Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.

Requirements

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