CONSULTANT SPECIALISTS, INC. (CSI)

2-10 employeeshttp://www.csi-it.com

Description

Consultant Specialists Inc. (CSI) is a full-service information technology staffing firm in the San Francisco Bay Area.

Locations
Head office

500 Beale ST., San Francisco , CA, USA, 94105

Project Manager Scrum Master

Septembre 16 | San Francisco, California, United States | CONSULTANT SPECIALISTS, INC. (CSI)

Project Manager Scrum Master

San Francisco, California, United States | CONSULTANT SPECIALISTS, INC. (CSI)

{"en":"Project Manager Scrum Master"}

Opening date:Septembre 16

Closing date : Octobre 17 2020

Computer Software

Job description

W2 ONLY. No exceptions

Candidates who are located San Francisco Bay Area are ideal. If you are not local but want to be considered, for this role, you will need to take care of your re-location on your own.

Please email your resume attached as a Word Doc to Ellen through this website.

PM Clinical / Molecular Strategy

Project name: CRISP (Connecting Regulatory Insight & Policy)

Project vision is to build a knowledge management database related to molecule strategy.

PDR currently has strategy and insights regarding molecule strategy in various places such as ppt, gdoc, etc. When a new molecule is being developed, the scientists often have to rely on their network to procure data and information to help them design their molecule strategy.

A database will enable them to pull relevant data and learning from "precedents" when required, help them make better decisions and enable more efficient interactions with health authorities. They will build operational and analytical dashboards on top of the database.



Key skills required of the PM/Scrum master-

  1. Ability to partner with the business closely and contribute to project strategy, governance, and light OCM/training/adoption planning activities
  2. Ability to lead through ambiguity (at least initially)
  3. Agile mindset is important. He/she may not play an active scrum master role but will manage scrum masters and will be seen as an agile coach/influencer to the team
  4. Experience with vendor solution analysis/negotiation
  5. Experience running POCs
  6. Business and IT team members are primarily in SSF, but there is a small development team in Poland
  7. 50% allocation suffices at this time. It will ramp up to 100% as the POC comes to a close and it spins off into a project
  8. Knowledge of clinical and regulatory domain is a huge plus
  9. Experience working with IT Security, Privacy, Quality on SRAs, DCRs, Vendor assessments is important

Regulatory Experience in Healthcare

Pharma regulatory applications, data and processes

Required

  • DATA GOVERNANCE
  • AGILE PDM
  • PROJECT MANAGER
  • VENDOR NEGOTIATIONS

Biomarker Operations Project Manager

Septembre 16 | San Francisco, California, United States | CONSULTANT SPECIALISTS, INC. (CSI)

Biomarker Operations Project Manager

San Francisco, California, United States | CONSULTANT SPECIALISTS, INC. (CSI)

{"en":"Biomarker Operations Project Manager "}

Opening date:Septembre 16

Closing date : Octobre 17 2020

Information Technology (IT)

Type:Contract (12 months)

Job description

10219601 Biomarker Operations Manager II

Work is ON-SITE in SOUTH SAN FRANCISCO

W2 ONLY - 12 Month Contract

Required

  • DETAIL ORIENTED
  • DIVERSE TEAM
  • GCP
  • PROJECT MANAGEMENT
  • VENDOR MANAGEMENT

Position Purpose:

  • Provides biomarker operational expertise and guidance to one or more cross-functional global Study Management Teams (SMTs)
  • Ensures the timely and efficient delivery of all biomarker operational aspects of one or more studies through all phases (phase 1b-IV) supported by PD and stages (start-up, conduct and close-down), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations.

Level/Grade:

Main Responsibilities and Accountabilities:

  • Provides biomarker operational expertise and guidance to global Study Management Teams (SMTs)
  • Accountable for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker samples (including companion diagnostic samples) * (collection, processing, analysis, data delivery process and final sample disposition) .
  • Responsible for collaborating closely with biomarker scientists and Biomarker
  • Operations Program Leaders (BOPLs) to execute biomarker operational strategies, serving as a single point of contact for biomarker operations on multiple SMTs, and with internal and external stakeholders.
  • Develops and maintains effective working relationships with SMT members, with particular

focus on the operational team, diagnostic partners, external CRO & Central Lab (for outsourced teams), and external biomarker vendors, where applicable

  • Builds and maintains effective and efficient high performing biomarker sample* analysis & data delivery . Supports relevant stakeholders in their accountabilities, responsibilities and deliverables to drive decisions on timelines
  • Responsible for the identification and selection of biomarker vendors in collaboration with the BOPL, biomarker scientist, GPPS and diagnostics/CDx managers; ensuring appropriate cross-functional input is incorporated into the scope of work
  • Ensure collection, delivery and analysis of biosamples under the highest standards of quality, ethics, and informed consent at study level
  • Manages the development and oversight of the biomarker analysis timelines, budget, risk and quality plans,
  • Ensures biomarker operational tracking and project management tools are utilized to meet the needs of the operations team and ensures reporting to the Biomarker
  • Operations Program Leader (BOPL).
  • Supports the development of the biomarker analysis budget and manages it on a study level. Communicates variances in the budget to the BOPL or GSM as appropriate.
  • Establishes biomarker sample analysis and data delivery milestones and ensures accurate tracking and reporting of Biomarker sample* metrics.
  • Provides study level updates to stakeholders (BTALs & BOPLs), clinical study teams and biomarker teams including sample collection, assay status and analysis updates
  • Provides clinical biomarker operations expertise to ensure operational feasibility and delivery
  • Responsible for assessing feasibility for biomarker operations plans on clinical studies across related functions
  • Leads the development and finalization of the Biomarker Management Plan (BMP) based on input from scientific and operational stakeholders to execute biomarker operational strategies
  • Provides operational input and recommendations into all study related documentation (including protocol, informed consent form, and amendments) and processes.
  • Attends operations team meetings and investigator meetings, monitor training, CRO kick-off meetings, as applicable, to deliver presentations and in-depth trainings to internal and external stakeholders on biomarker and companion diagnostic sample collection and handling procedures
  • Provides responses to biomarker sample* related questions or issues from Health Authorities.
  • Provides biomarker* operational input into the development of protocol feasibility questionnaires to ensure sites can meet sample-handling needs for the study
  • Provides input into the development of SMT goals.
  • Delivers the operational elements of the biomarker management plan
  • Proactively manages biomarker sample analysis and data delivery timelines and communicates any variances to the SMT, BOPL and biomarker scientists and implements contingencies in consultation with key stakeholders.
  • Primary contact for internal and external stakeholders to maintain oversight of biomarker vendor performance, issues, their resolution and coordinates any corrective action in collaboration with GPPS.
  • Actively partners with Data Acquisition Specialists and Data Management to oversee and coordinate biomarker data format and delivery timelines
  • Provides the day-to-day operational management of biomarker vendors to ensure delivery against contracted scope of work
  • Partners with internal/external stakeholders in the central lab set up, providing sample collection and processing instructions, kit contents, shipping conditions and logistics for biomarker samples
  • Performs ongoing biomarker vendor management including development and oversight of scope of work, budgets (invoice review & reconciliation) and performance management
  • Serves as primary point of contact for laboratories performing biomarker analysis and hence supports the biomarker outsourcing process through effective vendor management
  • Identifies areas of best practice and process improvements
  • Participates in Product Development Global Operations initiatives and programs as assigned
  • May lead or be a representative on functional groups goals, initiatives and work-streams
  • Ensures study adherence to ICH/GCP and SOPs

*in some cases may also be applicable to bioanalytical samples in partnership with the bioanalytical managers

Technical Requirements:

Qualifications:

  • Life sciences degree (Bachelor or Masters) in Scientific, Medical or Healthcare subject area required. Further qualification, e.g. PhD and/or project management certification is desirable.
  • 3+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment

Skills & Knowledge:

Experience

  • Extensive clinical development experience with evidence of working in teams running clinical studies
  • Pharmaceutical industry experience or experience working as a clinical trial coordinator within a clinical trial setting is a plus
  • Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples
  • Project management skills
  • Critical reasoning skills including the identification and resolution of complex problems
  • Detail oriented with the ability to work independently and manage multiple competing priorities
  • Planning, organizational and time management skills
  • Highly flexible in a fast pace global matrix environment
  • Professional interpersonal skills, excellent oral/written communication and influencing skills
  • Proven leadership skills, ability to successfully achieve results within a multi-cultural and geographically diverse team
  • Creates team culture and promotes team spirit.
  • Global Vendor Management experience preferred
  • Good knowledge of ICH GCP

Competencies

  • Strategic Agility
  • Inspiring and Influencing
  • Teamwork and Collaboration
  • Communication
  • Technical and Business Expertise
  • Achieving Results

Additional

  • PROJECT MANAGER
  • INVOICE
  • OPERATIONS
  • RECONCILIATION
  • TIME MANAGEMENT
  • BIOANALYTICAL
  • BIOTECHNOLOGY
  • CLINICAL RESEARCH
  • CLINICAL STUDIES
  • CLINICAL TRIAL
  • COLLECTION
  • ICH/GCP
  • LABORATORY
  • LEADERSHIP SKILLS
  • LIFE SCIENCES
  • LOGISTICS
  • PROCESS IMPROVEMENTS
  • PRODUCT DEVELOPMENT
  • SHIPPING
  • SOPS