Biotrial, Inc.
Clinical Research Data Manager Project Leader
Biotrial, Inc., Newark, New Jersey, us, 07175
Biotrial is a leading Contract Research Organization (CRO) specializing in Drug Development with a wide range of expertise in preclinical pharmacology, clinical development, bioanalysis, biometrics and ECG, and CNS and Imaging Core Lab. With over 30 years of experience in providing scientific and medical services in clinical development, Biotrial offers innovative, tailor-made solutions to Biotech and Pharmaceutical companies. By joining our Company in one of our locations in Europe or America, you become part of a high-performing organization and teams. Teamwork and cooperation between departments allow us to offer state-of-the-art services. You will therefore be required to interact in a supportive manner with different departments.We are seeking a clinical
Data Manager Project Leader
to join our team. In this position, you will be the main contact for the sponsors of our studies and the project team set up (data managers, statisticians, clinical project managers, clinical research associates, etc.).Responsibilities of the
Data Manager Project Leader M/F :Participation in the implementation of studies.Drafting the CRF and the Data-Management specifications.Participation in the data review meeting.Implementation of e-FIUs.Tracking of input, external data loading, data validation, coding.Drafting and monitoring of the documentation from the data management plan to the Data-Management report before the freeze of the database.Monitoring compliance with deadlines in agreement with the Director of the Data-Management Unit.Participation in the updating of procedures.Education and Experience:Bachelor's degree required, preferably in a scientific discipline or equivalent experience, Master’s preferred.A minimum of five (5) years’ experience in Data Manager and/or Product Leader, with expertise in clinical trials.Proven experience in Biotech/Pharmaceutical Industry.Proficient knowledge of ICH, GCP, GLP and applicable CFRs, guidance documents, systems processes, and procedures.Experience in clinical operations and handling trial essential documents is preferred.Skills and Abilities:Excellent communication and negotiation skills, and enjoys working with people and information, making decisions, problem-solving, making a difference and working in a leadership role.Adheres to ethical and good clinical practices and the ability to work as part of a team, as well as work independently.Excellent organizational skills and the ability to successfully work on multiple projects with competitive timelines.Strong attention to detail and respect for the accuracy of information with a solid commitment to maintaining high-quality standards.Excellent oral, written and interpersonal communication, organizational skills.Exceptional analytical and mathematics skills required.Must be able to travel (25%) including the potential for international travel.Intermediate to advanced software skills (e.g., Microsoft Excel, PowerPoint, Microsoft Project).Demonstrated ability to work effectively in a cross-functional team environment.Ability to analyze information and solve problems relating to all processes within a clinical research environment.Knowledge of SAS software.Biotrial is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, genetics, disability, age, veteran status, or any other characteristic protected by law.Job Type: Full-timeBenefits:401(k)401(k) matchingDental insuranceHealth insuranceLife insurancePaid time offReferral programVision insuranceSchedule:Monday to FridayExperience:biotech or pharmaceutical: 3 years (Required)SAS software: 3 years (Required)Ability to Commute:Newark, NJ 07103 (Preferred)Ability to Relocate:Newark, NJ 07103: Relocate before starting work (Required)Work Location:
Hybrid remote in Newark, NJ 07103
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Data Manager Project Leader
to join our team. In this position, you will be the main contact for the sponsors of our studies and the project team set up (data managers, statisticians, clinical project managers, clinical research associates, etc.).Responsibilities of the
Data Manager Project Leader M/F :Participation in the implementation of studies.Drafting the CRF and the Data-Management specifications.Participation in the data review meeting.Implementation of e-FIUs.Tracking of input, external data loading, data validation, coding.Drafting and monitoring of the documentation from the data management plan to the Data-Management report before the freeze of the database.Monitoring compliance with deadlines in agreement with the Director of the Data-Management Unit.Participation in the updating of procedures.Education and Experience:Bachelor's degree required, preferably in a scientific discipline or equivalent experience, Master’s preferred.A minimum of five (5) years’ experience in Data Manager and/or Product Leader, with expertise in clinical trials.Proven experience in Biotech/Pharmaceutical Industry.Proficient knowledge of ICH, GCP, GLP and applicable CFRs, guidance documents, systems processes, and procedures.Experience in clinical operations and handling trial essential documents is preferred.Skills and Abilities:Excellent communication and negotiation skills, and enjoys working with people and information, making decisions, problem-solving, making a difference and working in a leadership role.Adheres to ethical and good clinical practices and the ability to work as part of a team, as well as work independently.Excellent organizational skills and the ability to successfully work on multiple projects with competitive timelines.Strong attention to detail and respect for the accuracy of information with a solid commitment to maintaining high-quality standards.Excellent oral, written and interpersonal communication, organizational skills.Exceptional analytical and mathematics skills required.Must be able to travel (25%) including the potential for international travel.Intermediate to advanced software skills (e.g., Microsoft Excel, PowerPoint, Microsoft Project).Demonstrated ability to work effectively in a cross-functional team environment.Ability to analyze information and solve problems relating to all processes within a clinical research environment.Knowledge of SAS software.Biotrial is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, genetics, disability, age, veteran status, or any other characteristic protected by law.Job Type: Full-timeBenefits:401(k)401(k) matchingDental insuranceHealth insuranceLife insurancePaid time offReferral programVision insuranceSchedule:Monday to FridayExperience:biotech or pharmaceutical: 3 years (Required)SAS software: 3 years (Required)Ability to Commute:Newark, NJ 07103 (Preferred)Ability to Relocate:Newark, NJ 07103: Relocate before starting work (Required)Work Location:
Hybrid remote in Newark, NJ 07103
#J-18808-Ljbffr