Director, Clinical Data Management(FD20-231)
We provide ample scientific challenges enabling you to have a real impact in an environment where you get the opportunity to take part in the entire biotech value chain from the earliest drug discovery all the way through late stage clinical development. We expect you to bring an innovative mindset, scientific curiosity, a lot of energy and pragmatism.
We are currently seeing a Director, Clinical Data Management for our South San Francisco office, reporting to our VP of Clinical Operations.The incumbent will be responsible for providing accurate, timely, and consistent clinical data to support business objectives. They will define the data management workflow for assigned projects, and ensures all necessary data quality control measures are in place and serves as the data management expert on multidisciplinary internal department and external project teams providing specific expertise on timeline development and identification of data management deliverables. Primary guide for the execution of Clinical Data Management activities to support study start up, in stream production data review, and database closure and archiving. Works extensively with project management group and clinical team.
ABOUT CATALYST BIOSCIENCES
Catalyst is a clinical-stage biopharmaceutical company focused on developing novel medicines to address important unmet needs within bleeding and complement related disorders. Catalyst has compounds that span the value chain from the earliest discovery to late stage clinical trials with the intent of commercialization.
- Serve as the primary Data Manager on all aspects of program(s), including proactive communication with team members, to ensure consistent and cohesive data handling and quality
- Manage all of the operational aspects of data management activities within clinical trials in compliance with ICH/GCP guidelines and other processes
- Review clinical data, as per SOPs, protocols, and study specific guidelines
- Issue queries within the clinical database for missing, inconsistent, illegible, or erroneous data, and follow queries to resolution and close-out
- Interface and collaborate with project management, clinical and other teams on study start up activities, including case report form design, edit check development, and user acceptance testing
- Ensure quality completion of all clinical data cleaning, including external data cleaning and transfers
- Assist in clinical database closeout activities, including listing review, audit activities, etc.
- Communicate data issues and/or query trends to senior management and project teams as appropriate
- Interact with various Data Management and other functional area colleagues, including, Clinical Operations, Clinical Development, Project Management, etc.
- Maintain all relevant data documentation and key decisions associated with each assigned Protocol
- Take on responsibility for program of studies to ensure the Data Management aspects of a study and associated documentation are consistent across studies
- Participate in study/project team meetings as primary Clinical Data Management representative, providing updates on study status to the cross functional team
- Manage timelines for assigned protocol(s) and ensure that all applicable deliverables are on target for all Client Company deliverables
- Assess issues/generate solutions in data handling created by the changing requirements in clinical data processing
- Escalate any potential or actual issues to supervisor, project team, and/or Senior Management in a timely manner, and follow issues through to resolution
- Prepare presentations and/or training sessions and present to applicable study team members at meetings
- Develop, review and maintain study related documentation, including Data Management Plan, study specific guidelines, edit checks, data entry guidelines, etc.
- Participate in departmental initiatives including SOP development and templates
- Reconcile electronic data transfers from vendor to Sponsor
- Coordinate the archiving of study databases and related documents
- BA/BS degree with 4 - 5 years clinical data management experience
- Experience leading or co-leading protocol(s)
- Understanding of ICH/GCP guidelines and protocol and clinical drug development processes, clinical study design, study planning and management
- Experience managing CROs and other vendors and experience working on global project teams preferred
- Demonstrated knowledge of Clinical Data Management processes in a biotechnology or pharmaceutical setting
- Excellent verbal and written communications skills and ability to interact with personnel at all levels cross-functionally
- Proven leadership skills, executive presence, maturity, emotional intelligence, attention to detail, excellent written and verbal communication, problem solving with various working assumptions, intangible variables and incomplete information
- Strong organizational and time management skills
- Ability to serve as a primary point of contact for all study related personnel
- Ability to effectively present Data Management related materials as necessary
- Experience and knowledge in working with relational databases, file manipulation, table structure
Please send CVs/resumes directly to Human Resources, firstname.lastname@example.org referencing job number FD20-231 in the subject line.