Associate Director / Director, Clinical Data Systems Programmer & Administrator

Position Title: Associate Director / Director, Clinical Data Systems Programmer & Administrator
Location: Remote
Experience Level: Senior
Experience Required: 10 Years
Education Level: Bachelor's Degree
Reports To: Senior Director, Clinical Data Management

A next generation biotechnology company based in San Diego that is leveraging its proprietary chemical proteomics platform to conduct proteome-wide footprinting of drug-protein interactions with unprecedented breadth and precision. Our technology allows us to screen, identify and optimize novel drugs that selectively bind virtually any protein, including proteins previously considered “undruggable”. Our pipeline and emerging programs reflect a matured and productive platform capable of delivering first in class drugs utilizing novel mechanisms of action (allosteric inhibitors, protein-protein interaction inhibitors, functional activators, degraders etc.) against undruggable targets in the oncology and immunology space.

They prize scientific excellence, creativity, team players and are committed to continued innovation. Our client has worked hard to create a collaborative and dynamic work culture where your ideas and discoveries are valued and will have an impact. This industry leader is growing and there are opportunities for mentorship and career progression.

Ranked on 2022 Top Workplaces list.

Opportunity Summary:

Reporting to the Sr. Director, Clinical Data Management, the Associate Director / Director, Clinical Data Systems Programmer & Administrator is responsible for the oversight of CRO compliance to industry and protocol standards for database development, co-develop future strategy for clinical data systems within clinical data management department, manage clinical trial data receipt, custody, user access management, and data exchange with internal and external partners (e.g., CROs, central vendors) using currently established systems and processes. The candidate must be able to work within the data warehouse/data lake to retrieve trial data for internal cross functional use. This opportunity also requires strong programming skills to create internal data listings, script development, custom reports, queries, and general quality checks of vendor supplied data. The role also provides support to internal team members for ad hoc requests and scheduled data reviews.

Essential Duties & Responsibilities:

• Co-develop the short term and long-term plan for the selection and integration of all clinical systems: (e.g., Medidata's Rave EDC, CTMS, eTMF).
• Assist in automating manual processes with Clinical Development (e.g., deviation handling, data transfers, custom reports/metrics).
• Provide cross functional guidance and expertise for best practices for system configurations, setup, and ease of use for downstream users.
• Act as the liaison and subject matter expert (SME) between clinical systems and system owners to ensure data integrity, system performance and functionality meet agreed upon expectations.
• Review and provide guidance regarding data handling in study specific documents {e.g., electronic case report forms (eCRFs). Data Management Plans (DMP), Data Transfer Plans/Agreements/Specifications (DTP, DTA, DTS) from third party vendors} to ensure compliance to the study protocol, industry standards, and best practices.
• Assess study eCRFs to ensure compliance with Clinical Data Acquisition Standards Harmonization (CDASH) and Clinical Data Interchange Standards Consortium (CDISC) standards {e.g., Study Data Tabulation Model (SDTM) while building an internal global library.
• Ensure activities are performed in accordance with applicable regulatory requirements {e.g., 21 CFR part 11, General Data Protection Regulation (GDPR)}
• Program scripts to manage, organize and extract trial data within the data warehouse/data lake.
• Use SAS or other programming language to program quality control data checks, create custom listings for clinical study team members, program clinical trial metrics such as Key Performance Indicators (KPIs), Key Quality Indicators (KQIs), and provide necessary data outputs to study team for data review activities.
• Strong understanding and experience to ensure clinical data systems are maintained in a validated state in accordance with industry and regulatory validation requirements.
• Author necessary standard operating procedures (SOPs) and other process documents to cover Clinical Systems programming and validation activities.

Education & Experience Requirements:

• Bachelor’s degree in related field, such as Statistics or Computer Science, or equivalent work experience in pharmaceutical, biotechnology, biologics, or medical device industry.
• 10+ years of experience in the following clinical trial areas:
• Intake, maintenance, extraction, and oversight of data repositories for assigned clinical trials.
• Programming support for clinical data management and other functional partners.
• Work with system owners to ensure clinical systems function as expected and initiate change control activities, when necessary.
• Able to effectively communicate and establish strong partnership with cross functional study team members {e.g., Biostatistics (BS), Clinical Operations (CO), Safety and Pharmacovigilance (SPV), Medical Sciences (Med Sci), Translational Sciences (TS), and Information Technologies (IT)}.
• Develop formal specifications for applicable Clinical Systems Programming outputs.
• Experience working in and managing GxP- regulated systems.
• Able to interact, communicate and partner with all levels within the organizational to ensure regulatory compliance, data protection/privacy requirements and to fulfill the department and corporate values and goals.
• Although the position does not require a statistician, strong and demonstratable experience with CDISC, CDASH and SDTM data requirements is required.
• Knowledge in dealing with large amounts of data from external sources.

Interview Process:

1. Phone interview with HR and/or Hiring Manager.
2. Phone screen with HR and/or Hiring Manager.

Pay & Benefits:

This position is eligible for target bonus, long-term-incentives, 401k retirement savings plan with company match, and a comprehensive benefits package which includes medical, dental, vision, life, and disability insurance. Relocation assistance may be available based on business needs and/or eligibility.

EEO & Employment Eligibility:

Our client is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.