Associate Director, Clinical Data Management at BeiGene, Ltd. APAC in Emeryville, California

Posted in Other 5 days ago.

Type: Full Time





Job Description:

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.General Description:* The Associate Director, Clinical Data Management role may be responsible for leading multiple clinical studies and/or multiple programs from the Data Management perspective. The role may also be responsible for process development and process improvement activities to ensure quality, compliance, consistency, as well as increase operational efficiency within Data Management. This role will report to the Director, Data Management.Essential Functions of the job:* Develop and drive Data Management standards and process improvement initiatives* Develop and maintain process documents (e.g., Standard Operating Procedures, Work Instructions) pertaining to Data Management activities* May drive and participate in Clinical Development taskforces and initiatives around standardization and technology* May drive inspection readiness, quality compliance, and training initiatives pertaining to Data Management* May lead and/or oversee multiple clinical studies and programs* May function as the Data Management primary point of contact for all study team members and vendor partners* May oversee day to day activities of data managers working on clinical studies within a program* May serve as an active member of Clinical Study Teams* May work with other functions to manage timelines and ensure that clinical data management deadlines are met* May create and maintain study specific data management documentation* May identify and troubleshoot operational problems, issues, obstacles, and barriers for studies, programs, and initiatives* May review and provide feedback on draft protocols, Statistical Analysis Plans, CSRs and other documents as required* Train and/or supervise the daily responsibilities of more junior staff as assigned* Train Data Management and cross-functional team members on SOPs, process and standards as required* Other duties as assignedSupervisory Responsibilities:* May have line management responsibilities, including the development of in-house Data Management staff as applicableEducation Required:Bachelor's degree or equivalent in a health-related field preferredOther Qualifications:* 10+ years of experience in Clinical Data Management in the pharmaceutical/biotechnology* Proficiency in all areas of Clinical Data Management activities* Excellent experience working in cross-functional team-oriented environments* Strong oncology experience preferred* Strong project management skills* Strong communication skills* Understanding of ICH and regulatory environment as it pertains to data management* Proven experience in internal and external inspection activities preferred* Working knowledge of one or more EDC systems, Medidata Rave preferred* Working knowledge of SDTM and CDASH principles and other industry guidelines preferredTravel:Minimal travel, approximately 2-3 times per yearCompetencies:Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.Adaptability - Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.Project Management - Communicates changes and progress; Completes projects on time and budget.We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.