Director Clinical Data Management Systems and Programming
- R+D/ Global Development Support
- Greater Bay area
- Salary Range $160-200k base + additional benefits
A clinical stage biopharmaceutical company is looking to hire a Director CDM Systems Integration and Programming. The position will be responsible for the planning, implementation, and overall direction of clinical data management systems development and maintenance and clinical data management programming activities. Responsibilities include managing clinical data handling policies, with a focus on preserving data security, veracity, and regulatory fulfillment. The role will lead efforts to recognize and operationalize effective results to meet Clinical Development requirements, which may include oversight of external business partners and technology vendors. This position co-operates closely with the rest of the Biometrics team, in addition to IT, QA, Clinical Science, Clinical Operations, and Safety personnel to ensure compliance with policies, procedures, and overall clinical objectives.
The Director position will have responsibilities that include:
- Spearheads the strategy and development of the Clinical Data Management Systems and Programming function.
- Verifies systems and processes to help ensure clinical data security and integrity.
- Operates closely with IT and QA to ensure that system infrastructure meet Biometrics needs and industry regulations and best practices.
- Standardizes and operates the clinical study data flow method to data delivery for analysis purposes.
- Leads clinical programming efforts for the purpose of clinical study data review to ensure data quality in support of clinical study data milestones and deliverables.
- Leads cross-functional standardization and process improvement initiatives.
- Identifies areas of deficiency requiring SOPs or guidelines and develops and executes a plan to rectify.
- Provides guidance in facilitating knowledge sharing and creation, leading to best practice and improved quality and processes in data management programming.
- Supervises the process to identify, evaluate and select external business partners and technology vendors. Responsible for contract negotiation and sign-off.
- Accountable for budget and resource planning across assigned projects.
- Recruits, trains, and manages employees and consultants within area of responsibility; Sets training standards.
- Manages group of internal and/or external team members. Mentors and develops direct employees.
The ideal candidate will have the following skill set:
- Minimum 8-10 years of clinical data management systems and programming experience in biotechnology or pharmaceutical industry, with outsourced CRO oversight experience; previous oncology experience required
- Minimum 7-8 years of Electronic Data Capture (EDC) experience
- Must have advanced knowledge of Data Management processes and systems
- Solid understanding of clinical drug development processes required
- Solid understanding of CDISC standards required
- Solid understanding of ICH, GCP, 21 CFR Part 11 required
- SAS programming experience required
- Experience with Medidata Rave preferred
- Data visualization software (such as Spotfire) experience preferred
- GCP systems validation experience preferred
- Agency filing and inspection experience preferred
- Must have demonstrated problem solving abilities in a team environment and strong organizational skills and the ability to work in a fast-paced environment
- Excellent written and verbal communication skills required
- Willing to travel on occasion