Eurofins Viracor, Inc.
BioPharma Program Manager
Viracor Eurofins is dedicated to being the leading specialty diagnostics laboratory partner in immunology, infectious disease, and allergy testing. We offer a range of unique clinical laboratory and biopharmaceutical services and provide exceptional test turnaround times. More than 4,000 healthcare providers, commercial laboratories, and biopharmaceutical companies rely on us for our unique and convenient services.
Viracor Eurofins is searching for a BioPharma Program Manager in Lee’s Summit, MO .
This is a Full Time position. Schedule is Monday – Friday, 8:00AM – 5:00PM, with overtime as needed. Candidates currently living within a commutable distance of Lee’s Summit, Missouri are encouraged to apply.
Basic Function and Scope of Responsibility:
The Project Manager is responsible for the successful planning, management, oversight of the BioPharma project management team that administer laboratory services in support of biopharma clinical trials. The Program Manager will be involved in the daily operations of clinical trial studies. The incumbent must have an expert and comprehensive understanding of GXP/GCLP requirements, principles, concepts, industry practices, and standards. Under the direction of the General Manager of BioPharma Services, the incumbent is responsible for managing a project management team through successful execution of BioPharma projects according to regulatory guidelines. S/he must facilitate effective internal and external relationships and is responsible for achievement of project goals and objectives on time and on budget.
Project Management Oversight
- Oversee the laboratory project management and Phase 1-4 clinical trials
- Directly manage, coach and mentor Project Managers, Data Managers and Data Coordinators (BioPharma Administration) on all applicable processes and systems
- Oversee and direct work of BioPharma Administration team to ensure projects are completed on schedule and within budget
- Act as primary trainer and subject matter expert for the BioPharma Administration Team
- Oversee BioPharma Administration response to internal non-confirming events and their associated corrective action plans
- Keep current on industry and legal trends, and regulatory and compliance requirements
- Ensure regulatory compliance of all project managers with company SOPs, regulatory guidelines
- Ensure effective project plans are in place and operational for each project and work proactively with the R&D; team, Lab Operations and vendors to set up priorities in accordance with applicable project plans, company standard operational procedures (SOPs), and regulatory requirements.
- Work with project managers to identify project risks and proactively suggests and implements mitigation strategies with internal and external partners
- Ensure potential study risks are escalated to the attention of the General Manager of BioPharma Services when appropriate
- Provide oversight to project managers on clinical studies and the process to identify and solve operational issues and drive delivery to plan through internal and external partners
- Prepare the design, format and content and/or provide technical expertise for the development of essential clinical documents (e.g. study reports, study plans, laboratory manuals, test request forms)
- Serve as the initial escalation point of contact for all project stakeholders
- Maintain frequent contact and work effectively with sponsors, central labs and CRO’s
- Ensure that data management standards are established for each project and adhered to through the study
- Routinely reviews study data and progress of enrollment; works with sponsor, or designee to address protocol variance.
- Coach project managers to identify out-of-scope tasks and escalate as required
- Contribute to the development and maintenance of a tracking utility with study level information to enable accurate and efficient supply of collection kits to sites
- Represent BioPharma Administration in external audits
- Contribute to the identification and implementation of process improvements
- Assist in screening and hiring of BioPharma Administration Associates
- Demonstrate strong leadership skills by effectively onboarding, training, and supervising work activities of team members
- Conduct regularly scheduled one-on-one meetings with direct reports focused on performance goals, progress, and career growth and development
- Assess team members by conducting effective performance reviews, and coach associates through necessary performance improvements
- Conduct regular team meetings and provide regular communication to team members
- Provide feasibility assessment and contribute to the response to biopharma proposal requests
- Support financial oversight of clinical studies through invoice tracking and reconciliation for potential change orders
- Review, reconcile and report on all project time reporting within the BioPharma Administration team, escalating variances to department Director
- Act as manager level interface with external partners for externally managed/outsourced activities
- Ensure accuracy of financial and sample receipt forecast and manage the overall accountability and reconciliation process
- Help to set Key Performance Indicators and lead reviews of key data to identify trends, discrepancies, errors, etc. to ensure ongoing quality of conduct in accordance with the protocol and sponsor contracts, incuding ongoing review and emerging data for tables, listings and figures.
- Track and report on key performance measures relevant to the BioPharma workflow
- Review and provide technical expertise for vendor/partner contracts.
- Leads the creation and revision of Standard Operating Procedures, guidelines, and departmental policies
- Coordinate closely with Research & Development, Lab Operations, IT, Finance, and Regulatory Affairs/Quality Assurance to ensure operational excellence in support of BioPharma projects
- Facilitate cross department meetings between BioPharma Administration and Lab Operations
- Represents BioPharma Administration on company-wide project teams
- Promote team alignment on cross-functional teams, and provide leadership and strategic direction
The Ideal Candidate would possess:
- Minimum of Bachelor’s degree, preferably in medical or biological sciences or discipline associated with clinical research from an accredited college or university. Advanced degree is preferred.
- Minimum of 3 years of related experience in support of Pharma/contract testing for clinical trials (phase I – IV), Clinical Diagnostics, Central Lab, Pharmaceutical or related healthcare field
- Direct experience in large scale clinical trials is a must
- Minimum of 3 years of Project Management experience
- Previous supervisory/management experience preferred
- Ability to prioritize tasks based on business needs
- Computer skills including proficiency in use of Microsoft Outlook, Word, PowerPoint, Excel, Access and Microsoft Project
- Effective written, verbal, presentation and communication skills
- Knowledge of clinical laboratory science preferred
- Excellent interpersonal skills, with ability to interact effectively and work efficiently with people at all levels in an organization
- Keenly attentive to detail
- Ability to keep sensitive information confidential
What we offer:
As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and vacation, personal days, and dental and vision options.
- Physical dexterity sufficient to use hands, arms, and shoulders repetitively to operate a keyboard and other office equipment, use a telephone, access file cabinets and other items stored at various levels, including overhead
- Ability to speak and hear well enough to communicate clearly and understandably with sufficient volume to ensure an accurate exchange of information in normal conversational distance, over the telephone, and in a group setting
- Ability to continuously operate a personal computer for extended periods of time (4 or more hours)
- Mental acuity sufficient to collect and interpret data, evaluate, reason, define problems, establish facts, draw valid conclusions, make valid judgments and decisions
The essential physical and mental requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work environment may consist of exposure to infectious disease, bio hazardous and hazardous materials, and regulated medical waste.
To learn more about Viracor Eurofins, please visit the following websites http://www.viracor-eurofins.com and www.eurofinsus.com .
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
With over 30 years of specialized expertise in infectious disease, immunology and allergy testing for immunocompromised and critical patients, Viracor Eurofins is committed to helping medical professionals, transplant teams, reference labs and biopharmaceutical companies get results faster, when it matters most. Viracor is passionate about delivering value to our clients by providing timely, actionable information — never losing sight of the connection between the testing we perform and the patients we serve.
We are looking forward to receiving your application including your expected salary and possible start date via our career website.
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