Johnson & Johnson companies are equal opportunity employers.
Trial Support Manager-0445140501
Description
Janssen Research & Development, L.L.C., a member of the Johnson & Johnson Family of Companies, is recruiting for a Trial Support Manager to be located in Springhouse, PA.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer’s disease, epilepsy, migraine prevention and treatment), pain management, and women’s health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.com.
The Trial Support Manager position is within the Biologics Clinical Pharmacology (BCP) Scientific Systems/Trial Support group. The Trial Support Manager will work with staff in Biologics Clinical Pharmacology to manage the databases of the sample collection, as well as the database of the results obtained from the analysis of these samples. Provide support with acquisition, storage, and disposition of clinical and non-clinical study samples. Set up Laboratory Information Management Systems (LIMS) database study templates, load and extract data. Serve as back-up support for Sr. Trial Support Manager and assist Sr. Trial Support Manager in delegation of work, as needed.
This individual will manage/participate in process and system optimization projects. Serve as a liaison between Biologics Clinical Pharmacology and the R&D Applications/Information Technology (IT) Gold department regarding new enhancements to the LIMS software. Participate in the completion of all activities related to Biologics Clinical Pharmacology clinical and non-clinical study deliveries. At times, oversee or assist with the completion of activities by other members of the group, to ensure timelines are met. Work with Global Clinical Operations Integrated Data Services (GCO IDS), Biologics Clinical Pharmacology, the Central Laboratory and the clinical trial teams when the assay sample management requirements are established for a trial. Review specifications documents from internal groups and Central Laboratories for studies where Biologics Clinical Pharmacology will be conducting analyses or receiving results. Define studies in ClinPharm LIMS for clinical studies so that samples can be receipted and analyzed. Deliver Pharmacokinetics (PK), Immune Response (IR) and PD results to Global Clinical Operations Integrated Data Services, Pharmacokinetics & Pharmacodynamics within BCP and/or CROs. Set-up and create labels for non-clinical studies and clinical studies where a central laboratory is not used. This individual will also serve as the Database resource for Biologics Clinical Pharmacology staff. Participate in the evaluation and implementation of new software and hardware sample management solutions.
Qualifications
Minimum of a Bachelor Degree required. A minimum 5 years in a clinical environment with clinical studies / trials, clinical data management, pharmaceutical CRO, clinical trials support in pharmacokinetic and immune response data generation and/or related experience is required. Experience with Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) highly preferred. Familiarity with execution of clinical trials highly preferred. Large molecule therapeutics experience preferred. Experience with Laboratory Information Management Systems (LIMS) strongly preferred. Central Laboratory interaction preferred. Demonstrated problem solving and decision making skills required. Excellent oral and written communication skills required. Ability to work in a team environment and collaborate with peers in a professional manner required. Ability to work in Springhouse, PA required.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI NA
Primary Location:North America-United States-Pennsylvania-Spring House
Organization: Janssen Research & Development, LLC. (6084)
Job Function: Clinical Trial Coordination
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
Trial Support Manager-0445140501
Description
Janssen Research & Development, L.L.C., a member of the Johnson & Johnson Family of Companies, is recruiting for a Trial Support Manager to be located in Springhouse, PA.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer’s disease, epilepsy, migraine prevention and treatment), pain management, and women’s health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.com.
The Trial Support Manager position is within the Biologics Clinical Pharmacology (BCP) Scientific Systems/Trial Support group. The Trial Support Manager will work with staff in Biologics Clinical Pharmacology to manage the databases of the sample collection, as well as the database of the results obtained from the analysis of these samples. Provide support with acquisition, storage, and disposition of clinical and non-clinical study samples. Set up Laboratory Information Management Systems (LIMS) database study templates, load and extract data. Serve as back-up support for Sr. Trial Support Manager and assist Sr. Trial Support Manager in delegation of work, as needed.
This individual will manage/participate in process and system optimization projects. Serve as a liaison between Biologics Clinical Pharmacology and the R&D Applications/Information Technology (IT) Gold department regarding new enhancements to the LIMS software. Participate in the completion of all activities related to Biologics Clinical Pharmacology clinical and non-clinical study deliveries. At times, oversee or assist with the completion of activities by other members of the group, to ensure timelines are met. Work with Global Clinical Operations Integrated Data Services (GCO IDS), Biologics Clinical Pharmacology, the Central Laboratory and the clinical trial teams when the assay sample management requirements are established for a trial. Review specifications documents from internal groups and Central Laboratories for studies where Biologics Clinical Pharmacology will be conducting analyses or receiving results. Define studies in ClinPharm LIMS for clinical studies so that samples can be receipted and analyzed. Deliver Pharmacokinetics (PK), Immune Response (IR) and PD results to Global Clinical Operations Integrated Data Services, Pharmacokinetics & Pharmacodynamics within BCP and/or CROs. Set-up and create labels for non-clinical studies and clinical studies where a central laboratory is not used. This individual will also serve as the Database resource for Biologics Clinical Pharmacology staff. Participate in the evaluation and implementation of new software and hardware sample management solutions.
Qualifications
Minimum of a Bachelor Degree required. A minimum 5 years in a clinical environment with clinical studies / trials, clinical data management, pharmaceutical CRO, clinical trials support in pharmacokinetic and immune response data generation and/or related experience is required. Experience with Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) highly preferred. Familiarity with execution of clinical trials highly preferred. Large molecule therapeutics experience preferred. Experience with Laboratory Information Management Systems (LIMS) strongly preferred. Central Laboratory interaction preferred. Demonstrated problem solving and decision making skills required. Excellent oral and written communication skills required. Ability to work in a team environment and collaborate with peers in a professional manner required. Ability to work in Springhouse, PA required.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI NA
Primary Location:North America-United States-Pennsylvania-Spring House
Organization: Janssen Research & Development, LLC. (6084)
Job Function: Clinical Trial Coordination
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement