Job Description :
Any visa/tax term

Clinical Apps Manager (GxP, IT R&D)

Sunnyvale, CA

Duration: 3 month CTH

*Salary: 150k

It is linical apps manager role, managing small teams and managed
services.
In a nutshell they need someone who can own their GxP applications and
manage teams and projects around the applications. They will need some come
from a life science or healthcare organization where these types of
applications are used.

Top 3:

Experience managing GxP applications (System Owner) 6+ years experience
Experience managing teams and MSPs
Experience in life sciences or healthcare organization
Core Job Responsibilities:
System Owner for GxP applications such as CTMS (BioClinica),
Oracle Argus Patient Safety, ComplianceWire, MasterContol and other
similarly classified R&D applications.
Work closely with Associate Director of IT & R&D Applications to
lead initiatives to improve IT R&D effectiveness and efficiency
Responsible for maintaining the validated state of IT R&D
applications to ensure compliance to regulatory standards
Managing a team of staff including programmers, analysts, and
managed service providers.
Selection and procurement of appropriate hardware and software
Implementing and managing security or integrity and backup
procedures and change management
Identify the criticality of selected application functions and
the expected service level goals for application operations and support
Identify the priority of IT R&D support and project requests
that impact the system
Knowledge of validation lifecycle of GxP computerized systems.
Ability to develop solutions to complex problems that require a
high degree of ingenuity, creativity, and innovation within the boundaries
of industry compliance regulation.
Establish partnership with Business SME s/end users for project
requirements
Managing IT R&D budgets, corporate software licensing policies
and procedures
Represent as System Owner in the event of Regulatory Audits and
Inspections
Manage R&D administration and operational support including user
and security management, provide inputs to process improvements.
Responsible for timely closure of IT R&D Exception Reports,
CAPAs and Deviations
Responsible for review and approval of IT R&D controlled
documents, policies, procedures, Work Instructions and vendor agreements

Other Skills:

Familiar with drug discovery, translational medicine, and the
IND/NDA process
Familiar with Enterprise wide systems LIMS/ RIMS implementation
and support
Familiar with Computer System Validation, SDLC and the Change
Control Process in Life sciences industry
The IT R&D Applications Manager should be comfortable working
with Business Owners, IT QA, Business QA and end users with differing
levels of technical expertise
Strong understanding of relational databases, database
programming skills and tools
Expected to deliver documentation and training with all solutions
Ability to plan and coordinate multiple simultaneous application
efforts
Quick learner, Analytical and problem-solving skills, with
ability to work under pressure
Attention to detail, Self-starter / tenacious problem solver /
highly motivated
Ability to take projects from design to long-term maintenance
Management and leadership capability
Excellent communication and documentation skills

Qualifications:

BS in a related field such as Information Technology/ Computer
Science/ Software Engineering
A minimum of 8-10 years practical work experience as an IT
System Owner is required with experience in a life sciences/healthcare
organization.
A minimum of 3-5 years practical work experience as an IT System
Administrator is required with experience in a life sciences/healthcare
organization.
Working knowledge of FDA, EMA regulations such as Annex 11, 21
CFR Part 11, Part 210, 211; Computer Systems Validation and GAMP framework.
Must understand the above standards and be able to deliver
compliant solutions.
Reviewing, and executing validation documents within the
Computer System Validation
Familiar with electronic ticketing and document management systems such as:
Service NOW, Trackwise, SharePoint and MS- Projects