Biosample Operations Specialist / Little Falls, NJ
Kelly Services is currently seeking a Biosample Operations Specalist for driving alignment of study and project level strategies within the overarching therapeutic area strategy for biosamples, through close partnership with the Biosample Therapeutic Area Leaders (BTALs), service providers (including lab vendors) and DTA stakeholders
- Responsible for the delivery and implementation of the biosample strategy within multiple clinical programs in accordance with the requirements of quality, ethical and regulatory standards including ICH/GCP/GLP
- Ensures project level consistency for biosampling across studies and is the primary point of contact within Biosample Operations for project, clinical and study teams
- Delivers expert input on strategic direction and operational considerations for Biomarker sampling to project and study teams
- Leads or contributes to innovation and continuous improvement activities in the area of biosample collection, processing and data delivery
Job Primary Responsibilities and Accountabilities:
- To provide operational expertise to ensure the successful implementation of the biosample strategy for a given molecule or clinical program
- To ensure the appropriate level of sample quality, defining corrective actions if necessary, and acting as a point of escalation for issues at the study and project levels
- To implement the biosample sourcing strategy within given projects through partnership with the BTAL and other key stakeholders involved in project and study delivery
- To be accountable for project level oversight (from feasibility to study close) of laboratories/vendors and associated costs involved in biosampling activities and analyses. Provides input to the laboratory selection process to ensure appropriate vendor selection where applicable
- Leads cross-functional operations team meetings as required to ensure optimal delivery of project biosampling objectives
- To actively promote knowledge sharing within Clinical Operations and across studies within a project by partnering with stakeholders.
- To be accountable for the accurate and timely forecasting and management of individual project and study variable costs related to bio-sampling, in collaboration with key stakeholders
- To provide regular project/study level biosample status updates to key stakeholders as required.
- To act as a subject matter expert within the Clinical Operations for specific business-related topics or processes
- To contribute to, and occasionally lead, functional process and system improvements to ensure operational excellence
- Mentor others as required to maximize their capability and contribution to deliver high quality biosamples
- Partner with cross functional parties and external vendors to communicate and train on relevant processes which underpin the laboratory operating model
- To contribute to a positive and motivating work environment that encourages mutual respect, innovation and accountability at all levels through role modelling the Roche values of courage, passion and integrity
- Ensures implementation of the ethical and legal framework for biosampling
Experience, Skills, Knowledge
- Significant experience implementing clinical trials – required
- Extensive experience in leading and managing biosample operational activities on a range of logistically complex multi-center clinical studies, - preferred
- Demonstrated knowledge of ICH GCP
- Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples
- Demonstrated leadership skills
- Proven ability to successfully achieve results within a multi-cultural and geographically diverse matrix environment
- Proven ability to influence effectively and confidently within a matrix environment
- Knowledge of legal and regulatory environment related to human specimen collection, analysis and retention
High Performance Competencies
- Effective communication skills
- Ability to lead and work across a global matrix team and stakeholder environment
- Ability to work independently and manage multiple competing priorities
- Effective strategic agility
- Ability wo work with internal and external partners
- Excellent written and spoken English.
- Willingness to travel internationally and work cross-culturally
- Life Sciences degree or higher qualification
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Email email@example.com for questions about the position but please apply online to be considered for the position.
- As a Kelly Services employee, you will have access to numerous perks, including:
- Exposure to a variety of career opportunities as a result of our expansive network of client companies
- Career guides, information and tools to help you successfully position yourself throughout every stage of your career
- Access to more than 3,000 online training courses through our Kelly Learning Center
- Weekly pay and service bonus plans
- Group-rate insurance options available immediately upon hire*
*Available for purchase and administered by a designated third-party vendor
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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