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Sample Management Lab Project Manager - Italy- FSS
King of Prussia, PA
Job Description
OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team in the role of Sample Management Lab Project Manager. Your work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
MAIN RESPONSIBILITIES AND ACCOUNTABILITIES:
Responsible for the planning, oversight of testing and reporting of clinical serology across global portfolio of clinical trials (seasonal, pandemic and other trial as required): Provide serology expertise and input to clinical protocol and associated documents.
COMPETENCIES
EDUCATION
At minimum, BSc / MSc or equivalent in relevant immunology, medical, pharmacy, or other life-science discipline. PhD preferred.
TRAVEL REQUIREMENTS;
Domestic and international travel required. Amount dependent upon project needs.
ABOUT ADVACNED CLINICAL
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives
We are currently searching for a skilled professional to join a well-known client's team in the role of Sample Management Lab Project Manager. Your work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
MAIN RESPONSIBILITIES AND ACCOUNTABILITIES:
Responsible for the planning, oversight of testing and reporting of clinical serology across global portfolio of clinical trials (seasonal, pandemic and other trial as required): Provide serology expertise and input to clinical protocol and associated documents.
- Responsible for project managing all aspects of the clinical serology lifecycle, including, but not limited to:
- Sample/swab collection protocols,
- Sample/swab shipment from clinical/investigator sites/depots to external vendor 300+ sites across 15+ countries),
- Ensuring testing is being conducted according to the optimised, validated protocol(s)
- Issue/risk identification and resolution; ensure escalation pathway to Snr/GCOL and/or Program Director, as needed.
- Management of budget for clinical serology testing and retention of samples
- Responsible for identifying, evaluating and selecting external vendors capable of conducting serology testing supporting pivotal global clinical trials. Accountable for oversight of clinical serology vendors and ensuring quality of data is robust and per validated protocols
- Responsible for managing clinical serology samples per country regulations and/or informed consent procedures. Capability to oversee and manage complex sample collection and shipping process across global regions (Asia Pacific, Americas (NA and LATAM) and Europe, Middle East and Africa).
- Review validation protocols for clinical serology testing and ensures testing is in compliance with clinical protocol, local regulations and Good Clinical Practice.
- Responsible for sourcing reagents and/or anti-sera from manufacturing facilities, Regulatory Agencies and/or External Reference Laboratories (WHO, CBER, NIBSC, TGA). Establishes and maintains close relationship with manufacturing facilities and External Reference Laboratories.
- In collaboration with Research and Technical Development serology functions drive optimization of assays and/or changes to testing procedures as requested by Regulatory Authorities
- Provision of serology expertise in responding to Regulatory Agency questions regarding serology testing
- Responsible for ensuring contracts with external serology testing and sample storage vendors are executed in a timely manner and are cost effective.
COMPETENCIES
- Demonstrated ability to lead teams and work in a fast-paced team environment.
- Experienced in working within a Matrix Environment
- Excellent interpersonal and decision making skills. Demonstrates innovation. Possesses drive, energy, and enthusiasm to deliver the program objectives.
- Specialist knowledge of serology and virology assays related to analysis of clinical trial samples.
- Established relationships within World Health Organization (WHO) and other relevant bodies
- Excellent understanding of all tasks involved in a clinical development program from developing a protocol through finalizing a clinical study report.
- Ability to plan and ensure execution and completion of serology testing to the highest ethical and scientific standards.
- Demonstrated ability to comprehend complex scientific concepts and data. Proficient in reviewing and assessing clinical data.
- Extensive and comprehensive knowledge of ICH guidelines/GCP, Maintains current medical/scientific/regulatory knowledge.
- Demonstrated project management skills including simultaneous management of multiple projects. Possesses excellent planning, time management & coordination skills.
- Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs.
- Excellent written and oral communication skills.
- Maintains computer literacy in appropriate software.
- As a guide, a minimum 6+ years' relevant clinical research (or related) experience within the pharmaceutical industry.
- Experience in overseeing global vendors supporting clinical trials, serology testing and sample storage
- Experience with project management software packages.
- Budget forecasting and management.
- Thorough knowledge of relevant test method validation guidelines and ICH guidelines / GCP.
- Ability to work independently with some oversight in the support and/or management of clinical trial execution.
EDUCATION
At minimum, BSc / MSc or equivalent in relevant immunology, medical, pharmacy, or other life-science discipline. PhD preferred.
TRAVEL REQUIREMENTS;
Domestic and international travel required. Amount dependent upon project needs.
ABOUT ADVACNED CLINICAL
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives
Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
6+ years
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