Senior Manager , IT R&D Clinical Systems
Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.
More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.
Pharmacyclics Inc. is searching for a qualified Sr Manager , IT R&D Clinical Systems who will be a vital link between our information technology department and our clinical business objectives by supporting and ensuring the successful completion of analysis, design, testing, deployment and support of systems that deliver value to our clinical stakeholders. This individual will plan an active hand on role in reviewing and documenting current state processes and recommending and designing future state business processes and working to improve operational efficiencies within our Electronic Data Capture Systems (EDC), Clinical Trial Management System (CTMS), Clinical Quality Management System (CQMS), Risk Based Monitoring Systems (RBMs), CRO Data Transfer, Analytics and other clinical systems. This role will work closely with the Clinical Systems Architect and Clinical Business - Clinical Information Systems team.
Responsibilities and Duties:
- Elicit document best practices and processes for using clinical systems and working with the user community to ensure adoption and operational efficiencies are achieved.
- Provide support and program management for Pharmacyclics's clinical systems including system configuration, process reviews, training, general system support and issue resolution as needed.
- Critically evaluate information gathered from multiple sources, reconcile conflicts decompose high-level information into details, abstracts up from low-level information to a general understanding, and distinguish user request from the underlying true needs.
- Proactively communicate and collaborate with internal customers to analyze information needs and functional requirements and identify areas that need improvement or updating.
- Successfully engage in multiple initiatives simultaneously as required.
- Strong analytical skills required, including a thorough understanding on how to interpret business needs and translate them into application and operational requirements in the healthcare industry.
- Ability to translate clinical requirement from the user community to technology team members.
- Excellent verbal and written communication skills and the ability to interact professionally with a diverse group of executives, managers, staff, and other subject matter experts.
- Serves as a key conduit between the clinical community, stake holders and the IT team members through which requirement and specification will flow.
- Develop requirements specification according to standard templates, using natural language.
- Collaborate with IT team members and other subject matter experts to establish the solution vision and analyze tradeoffs between clinical needs, compliance, usability, cost and efficiencies gained.
- Provide training and documentation of best practices for the clinical user community.
- Actively participate in the QA process as needed.
Minimum Qualification & Skill:
- Bachelor's Degree
- Experience in Business/ Systems Analysis, Clinical Trials Management, Quality Assurance and Pharmaceutical R&D processes
- Clinical systems experience as an analyst or a "Super-user".
- Healthcare industry experience
- Proven experience in eliciting requirements and testing
- Experience in analyzing data to draw business-relevant conclusions.
- Experience with data analysis and process flow diagrams a plus.
- Experience in cost/benefit and ROI analysis.
- Be result oriented and have a record of success in meeting deadlines.
- Requires the ability to meet rigid deadlines while multi-tasking.
- Clinical systems Analysis: 6 years (Required)
- Business/System analysis and quality assurance: 6 years (Required)
- Healthcare Industry: 6 years (Required)
Equal Opportunity Employer Minorities/Women/Veterans/Disabled