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Clinical Data Manager (Oncology)

THIS ROLE IS ONSITE IN EITHER WEST LOS ANGELES OR SOUTH SAN FRANCISCO. NO REMOTE OR TELECOMMUTE. W2 OR CORP TO CORP ONLY

 

Our Biotechnology client has an immediate need for a Clinical Data Manager on a long term contract basis to lead studies in Oncology areas. You will be responsible for coordination of CRF design, development, review and sign off ; Reviews and approves CRO generated Data Management documents, coordinates database live and close out activities with the CRO, provides guidance to CRO to manage query flow and implements quality control plan. The individual may participate in reviewing vendor audit plan and statistical analysis plan as needed; may participate in vendor qualification and selection as appropriate, and participates in monitoring vendor performance.

 

Responsibilities:

Able to lead a small clinical study or co-lead a larger study or studies with moderate guidance

Able to support several clinical studies with minimal guidance

Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies

Review protocols for appropriate data capture. Able to perform a thoroughly detailed review of data requirements.

Interact with CRAs, programmers, study managers and statisticians.

Develop data edit check specifications and run data listings as

Develop the Data Management Plan for a clinical study.

Able to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications

Enter data queries into the system to be resolved at investigational sites and manage the resolution of those queries

Perform reconciliation of header data from external data sources against the clinical database

Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines

Assist in database upgrades/migrations including performing User Acceptance Testing

Able to maintain study workbooks and data management files

Perform database lock and freeze activities per company SOPs

Participate in regular team meetings and provide input when appropriate

Provide input into the development of data management SOPs, Work Instructions, and process documents

Assist with the training of new employees and/or contractors

 

Requirements:

BA/BS, preferably in the scientific/healthcare field.

At least 5 years of experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment

Possesses an understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidances, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.

Experience and understanding of the Oncology therapeutic area, and with Phase III pivotal studies are desirable.

Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications. Prior experience with different Data Management systems and technologies.

Filed Under: CDM (Clinical Data Manager)

IT Systems Engineer (Santa Rosa, CA)

Summary:  The IT System Engineer is responsible for effective provisioning, installation/configuration, operation, and maintenance of systems hardware and software and related infrastructure. This individual participates in technical research and development to enable continuing innovation within the infrastructure. This individual ensures that system hardware, operating systems, software systems, and related procedures adhere to organizational values.

 

Areas of Responsibility: 

 

SA Engineering and Provisioning:

  • Engage with System/Network Admin Vendors, review invoices & contracts, recommend system improvements and processes, in-line with established business goals
  • Install new / rebuild existing servers and configure hardware, peripherals, services, settings, directories, SAN storage, etc. in accordance with standards and project/operational requirements
  • Develop and maintain installation and configuration procedures
  • Contribute to and maintain system standards
  • Research innovative, and where possible automated approaches for system administration tasks
  • Identify processes that leverage our resources and provides economies of scale
  • Assist in the management of existing servers, Voice, VM environment, and configure hardware, peripherals, services, settings, directories, storage, etc. in accordance with standards and project/operational requirements
  • Support various on premise server software solutions (WSUS, AD, DHCP, Uniprint)

 

Operations and Support:

  • Perform daily monitoring, verifying the integrity and availability of all hardware, server resources, systems and key processes, reviewing system and application logs, and verifying completion of scheduled jobs such as backups
  • Create, change, and delete user accounts per request
  • Provide Tier II/III/other support per request from various constituencies as needed. Investigate and troubleshoot issues
  • Repair and recover from hardware or software failures. Coordinate and communicate with impacted constituencies
  • Prepare users by designing and conducting training programs; providing references and support as needed
  • Maintain the PHC intranet, Service Desk, Office 365, PolicyTech, Amazon, and other Cloud Software solutions in consultation with support Vendors as needed

 

Maintenance:

  • Apply OS server patches and upgrades on a regular basis, and upgrade administrative tools and utilities. Configure / add new services as necessary
  • Maintain system software that supports Server Virtualization infrastructure applications or Asset Management applications per project or operational needs
  • Maintain operational, configuration, or other procedures
  • Perform periodic performance reporting to support capacity planning
  • Perform ongoing performance tuning, hardware upgrades, and resource optimization as required Configure CPU, memory, and disk partitions as required
  • Maintain data center environmental and monitoring equipment

 

Desktop Client Management:

  • Install, upgrade, and secure operating systems software and applications as needed
  • Support various on premise software solutions (eCW, Dentrix, Dexis)
  • Support Terminal Server and VDI environment, trouble shoot, and escalate issues if required
  • Perform regular security monitoring to identify any possible intrusions
  • Ensure the network security policy and standards for PHC are implemented:
    • Install appropriate firewalls, password protections, and anti-virus software
    • Install patch updates as appropriate
    • Ensure computer security as necessary, for example, by eliminating unnecessary services, minimizing unencrypted authentication, prevent unauthenticated email relays and uncontrolled access to proxy services, and providing for physical security

 

Printer Management:

  • Assist with firmware and driver maintenance on all supported printer servers
  • Configure various server and client operating systems for printing
  • Install, configure, and maintain network printers as needed
  • Troubleshoot and resolve fax server issues

 

Backup Management:

  • Set up systems for back up. Assist in maintaining and monitor daily logs.
  • Assist in resolving any client-side and server backup issues
  • Perform full and partial restores of servers as necessary
  • Assist in remote monitoring of backup jobs
  • Perform regular file archival and purge as necessary
  • Design client scripting and configuring of supported desktop/laptops for deployment
  • Review daily backup operations, ensuring all required file systems and system data are successfully backed up to the appropriate media, recovery media or disks are created, and media is recycled and sent off site as necessary

 

Phone and Video Communication Management:

  • Maintain and Support Vocera & VoIP Phone Systems
  • Program and distribute iOS devices as needed
  • Support Vocera Server and other Facility Systems – including MACs and licensing/troubleshooting of issues with the system in conjunction with the vendor
  • Support TV, Cisco Video, Webex, and Jabber messaging platforms
  • Telephony MACs and troubleshooting of issues (voicemail, phone not working, quality, etc.)

 

General Duties:

  • Assist with all other special tasks and manage projects as directed by management
  • Assist in troubleshooting hardware, software and network problems. File bug reports and follow-up to resolve problems with vendors
  • Collaborate with network engineers, architects and other team members on the implementation, testing, deployment and integration of network and server systems
  • Coordinate with other teams or departments to resolve user problems
  • Develop and participate in workflow documentation
  • Document helpdesk tickets as needed
  • Document, track, and monitor IT problems using applicable systems and tools
  • Document Server and Systems procedures
  • Evaluate and test stability of new products
  • Ensure that optimal inventory, and equipment management systems and processes are in place to support operations
  • Follow-up and update customer status and information
  • Limited staff training for commonly used applications (Webex, VPN, RPD, Office Suite, iOs)
  • Maintain computer and manual filing systems
  • Maintain and update location maps and IT device inventory as needed
  • Pass on any feedback or suggestions by customers to the appropriate internal team
  • Responsible for answering IT requests via phone, email, live chat or instant messages
  • Setup Projector, Laptop, Phones, and Mobile devices for staff meetings if needed
  • Study the “best practices” of other organizations and make recommendations regarding changes that would benefit PHC
  • Use security best practices
  • As needed, may be required to attend out-of-state training
  • Work across a broad range of technologies and liaises across multiple areas of the business to support incidents, problems and requests.
  • Participate in rotating on-call (after hours) support

 

Active Directory Administration:

  • Help assign user accounts and group creations as needed
  • Support on an ongoing basis, all systems for Moves, Adds and Changes (MACs) up to and including system access and modification. This includes but is not limited to:
    • Active Directory – add/change/disable Users, provide access to drives and resources as requested. Troubleshoot issues with Group Policy, scripting, drive mapping, printer mapping and others.

 

Other Duties:

  • Assists with other duties as directed

 

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

 

Education/Experience:

  • Bachelor’s degree with a technical major, such as engineering or computer science or equivalent; or six to eight years related experience and/or training; or equivalent combination of education and experience
  • Four to six years system administration experience
  • Experience with providing network security, including providing patches, anti-virus software, firewalls and password protection
  • Experience and knowledge of Apple hardware and software, including OS X Server, MSOffice for MAC
  • Experience with databases, networks (LAN, WAN) and patch management preferred
  • Knowledge of system security (e.g. intrusion detection systems) and data backup/recovery
  • Knowledge of networking and security, including TCP/IP, AFP, SMB, NFS, SFTP, SCP, SSH, SSL, OSI layer model
  • Knowledge and ability to provide support for various software packages including Microsoft products, eCW, and Dentrix
  • Knowledge to ensure network security policy and standards for PHC are implemented and enforced

 

Desired Skills:

  • Ability to manage multiple tasks & meet deadlines
  • Ability to effectively manage confidential information
  • Ability to troubleshoot problems under pressure
  • Ability to work and communicate effectively with staff
  • Attention to detail and problem solving skills
  • Critical thinking skills
  • Demonstrated ability to work alone and in a team environment
  • Effectively prioritize workload
  • Excellent planning, project management, and problem-solving skills, along with superior communication and interpersonal abilities
  • Effectively communicate clearly in person & in writing
  • Exhibits sensitivity to the needs and the situations of multi-cultural populations from a variety of income levels
  • Strong interpersonal skills
  • Strong customer service ethic
  • Promote and support PHC’s mission and vision
  • Proactive and responsible with excellent follow-up and customer service

 

Licenses and Certifications: 

  • VMware VCA certificate or Amazon AWS Certified Cloud Practitioner required
  • VMWare VCAP certification or AWS Certified Solution Architect preferred
  • Cisco or similar professional certification preferred
  • Microsoft MCSE certification preferred
  • ECW Certification (eCW Tech/eCW DS) preferred
  • ITIL Foundation Certification (ITIL -F) preferred
  • Current, valid California Driver License

 

Language Skills:  Bilingual in English and Spanish, both written and verbal preferred.

 

Mathematical Skills:  Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions and decimals.

 

Reasoning Ability:  Ability to recognize problems, collect data and establish facts.

 

Computer Skills:  Electronic Medical Records Experience Preferred. Experience with Microsoft Server/OS Platforms. Microsoft Office, Outlook, Word, and Excel. Use of a web browser.

Physical Demands:  The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Movement within health center complex environment repeatedly throughout the day
  • Ability to write by hand, use phone, use computer keyboard and mouse extensively to perform general office functions
  • Manual wrist and finger dexterity and wrist-finger speed sufficient to perform repetitive actions for extended periods of time
  • Ability to effectively communicate by hearing continuously and speech in a manner which can be understood by a diverse population
  • Ability to give and follow verbal and written instructions with attention to detail and accuracy
  • Must have visual acuity near and far (20 inches to 20 feet), depth perception, field of vision, ability to focus on an object, ability to identify and distinguish colors
  • Ability to sit or stand for extended periods of time (minimum periods of one (1) hour at a time)
  • Ability to frequently walk, bend, squat, stoop, kneel, twist, crouch, and climb with the use of a step stool
  • Ability to grasp, hold and pick up and reach with hands and arms
  • Ability to frequently lift and or move up to fifteen (15) pounds
  • Ability to occasionally lift and carry up to seventy-five (75) pounds (periodic lifting of supplies or equipment)
  • Ability to coordinate multiple tasks simultaneously
  • Ability to travel to and from other health center sites and community locations

 

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

 

While performing the duties of this job, the employee is regularly exposed to general office and health center area environment with frequent interruptions by staff, visitors and phones.  The work environment is a clean, well-lit, well-ventilated, and temperature controlled environment.  The noise level in the work environment is usually moderate.  The hours of duty are Monday through Friday during the business day.  The employee must be willing to work varied hours to accommodate meetings, projects, and special functions, sometimes with limited notice. On-call coverage may be requested.

 

 

 

 

 

 

Filed Under: IT Systems Engineer

SQL Server DBA (Operations focused)

 

 

SQL Server DBA

 

 

PRIMARY RESPONSIBILITIES

This is a MS SQL Server DBA role largely responsible for providing operational database services to the organization. Some of the primary responsibilities of this role would include owning, tracking and resolving database related incidents and requests, fulfilling requests and resolving incidents within SLAs, reviewing service related reports (e.g: database backups, maintenance, monitoring) on a daily basis to ensure service related issues are identified and resolved within established SLAs, responding to database related alerts and escalations and working with development and engineering to come up with strategic solutions to recurring problems.

This MS SQL Server DBA role requires a service oriented mentality, high sense of ownership of the problems and requests assigned, focus on managing and resolving issues in alignment with the SLAs, establishing and maintaining communication with technology customers to keep them updated with status of their requests, initiating and performing changes on production systems and proactively escalating any issues that cannot be resolved within the established timeframes.

 

QUALIFICATIONS

US citizens and Green Card Holders and those authorized to work in the US are encouraged to apply.  We are unable to sponsor H1b candidates at this time

Must-have:
  • At least two years of experience supporting MS SQL Server technologies.  SDLC experience is important as the individual will be asked to assist developers with our in-house developed Practice Management System.
  • Experience with data replication and mirroring technologies and Microsoft SQL Server 2014 experience is a big plus.
  • Technologies and skills: MS SQL Server, Visual Studio,  SSIS, SSRS, SSAS, and TFS.
  • Database design and implementation experience – OLTP and OLAP database schema design, stored procedures, XML, FileStream, FileTables, etc.
  • Experience in developing reports using Business Intelligence tools (e.g. SSRS, Crystal Reports.)
  • Education: Bachelor’s degree or above in Computer Science, or related Engineering discipline or years of experience.
  • Business domain knowledge and experience in healthcare (nice to have).
  • DB administration experience – Managing geographically dispersed databases.  Database monitoring.  Database setup, configurations, and tuning, Hot/Cold backup and recovery, etc.
  • DB administrative tools: including SQL Server Management Studio, SQL Server Profiler, SQL Server Agent, etc.
  • Disaster recovery – Active/Active, warm standby, other DR setups.
  • Knowledge of various regulations, e.g. SOX, PCI. (nice to have)

 

Further, the ideal candidate will be a true team player with a commitment to success, and will be able to thrive in a fast-paced, rapidly changing environment.  Your excellent communication skills, strong analytical, problem-solving, and troubleshooting skills will be greatly appreciated.

Filed Under: SQL Server DBA

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13636 Ventura Blvd. Suite #425
Sherman Oaks, CA. 91423
818.762.0800
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