ClinChoice Inc.
Senior Project Manager
ClinChoice Inc., Horsham, Pennsylvania, United States, 19044
ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house US team as a Senior Clinical Project Manager. You will work on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device and consumer health companies.
As Senior Clinical Project Manager you will be responsible for leading cross-functional teams and managing complex projects. You will also ensure quality of the services in accordance with contractual obligations, applicable SOPs, ICH-GCP guidelines and other applicable regulations. Previous experience working with a CRO, managing oncology and respiratory trials is required. This role is a full-time hybrid opportunity. The office is located in Horsham, Pennsylvania.
Join our global team and help improve peoples' lives!
Main Job Tasks and Responsibilities:
Manage and coordinate the assigned clinical projects.
Manage all project specific services required by the Sponsor (central lab exams, drug shipments, document shipments, etc.).
Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team members.
Keep professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assigned.
Knowledgeable in the application process for clinical studies, in force in the country/ies of work.
Collect and manage study data documentation (CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, correspondence, etc.).
May act as a Technical Specialist supervising the projects within specific therapeutic and technical areas.
Assure the proper timelines of the assigned projects.
Manage the budget for the project.
Monitor the workload and the performance of the project team.
Plan and monitor the tasks of the team in the specific areas.
Coordinate the Clinical Research Associates and Clinical Monitors activity.
Collaborate with the Clinical Trial Administrators and Clinical Research Associates in terms of local authorities approval activities.
Collaborate in the overall management of the project with the assigned Biometrics team and with all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.).
Collaborate with the CTAs in archiving activities.
Assist the Medical Monitor in preparing protocols, Case Report Forms, and final Clinical Study Reports.
Deliver project specific trainings.
Organize and participate in Monitor and Investigator Meetings.
Organize or take part in the periodic project update meetings.
Provide project updates to the Sponsor, Senior Project Manager and Project Director/Leader as required.
Inform the Project Director/Leader about any issues.
Perform co-monitoring visits for the assigned clinical projects as necessary.
Act as a tutor for Project Coordinators and Project Manager I.
Maintain relationships with the Sponsor, including providing project updates.
Prepare the SOPs relating to clinical research activities in collaboration with the Quality System Unit.
Collaborate in complying and enforcing Company procedures.
Education, Experience and Skills:
Bachelor's Degree or equivalent University Degree in scientific and/or medical or paramedical disciplines; Nursing degree or relevant degree or background preferred. In some cases, an equivalency, consisting of a combination of appropriate education, training and or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Eight (8) years (at least) of clinical research experience in Project Management.
Previous experience managing oncology and respiratory studies is required.
Previous CRA experience is highly desirable.
Previous CRO experience is required.
Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements.
Prior experience in electronic data capture preferred.
Fluent in English.
Proficiency in Microsoft Office (e.g. Word, Excel, Outlook).
The Application Process:
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice:
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!
Our Company Ethos:
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
Key words:
Senior Project Manager, Senior Clinical Project Manager, Senior Study Manager, Study Management, Project Management, Medical Devices, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Study Management, Project Leader, Project Lead, complex clinical trials, oncology, respiratory, CRO, Contract Research Organization
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As Senior Clinical Project Manager you will be responsible for leading cross-functional teams and managing complex projects. You will also ensure quality of the services in accordance with contractual obligations, applicable SOPs, ICH-GCP guidelines and other applicable regulations. Previous experience working with a CRO, managing oncology and respiratory trials is required. This role is a full-time hybrid opportunity. The office is located in Horsham, Pennsylvania.
Join our global team and help improve peoples' lives!
Main Job Tasks and Responsibilities:
Manage and coordinate the assigned clinical projects.
Manage all project specific services required by the Sponsor (central lab exams, drug shipments, document shipments, etc.).
Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team members.
Keep professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assigned.
Knowledgeable in the application process for clinical studies, in force in the country/ies of work.
Collect and manage study data documentation (CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, correspondence, etc.).
May act as a Technical Specialist supervising the projects within specific therapeutic and technical areas.
Assure the proper timelines of the assigned projects.
Manage the budget for the project.
Monitor the workload and the performance of the project team.
Plan and monitor the tasks of the team in the specific areas.
Coordinate the Clinical Research Associates and Clinical Monitors activity.
Collaborate with the Clinical Trial Administrators and Clinical Research Associates in terms of local authorities approval activities.
Collaborate in the overall management of the project with the assigned Biometrics team and with all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.).
Collaborate with the CTAs in archiving activities.
Assist the Medical Monitor in preparing protocols, Case Report Forms, and final Clinical Study Reports.
Deliver project specific trainings.
Organize and participate in Monitor and Investigator Meetings.
Organize or take part in the periodic project update meetings.
Provide project updates to the Sponsor, Senior Project Manager and Project Director/Leader as required.
Inform the Project Director/Leader about any issues.
Perform co-monitoring visits for the assigned clinical projects as necessary.
Act as a tutor for Project Coordinators and Project Manager I.
Maintain relationships with the Sponsor, including providing project updates.
Prepare the SOPs relating to clinical research activities in collaboration with the Quality System Unit.
Collaborate in complying and enforcing Company procedures.
Education, Experience and Skills:
Bachelor's Degree or equivalent University Degree in scientific and/or medical or paramedical disciplines; Nursing degree or relevant degree or background preferred. In some cases, an equivalency, consisting of a combination of appropriate education, training and or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Eight (8) years (at least) of clinical research experience in Project Management.
Previous experience managing oncology and respiratory studies is required.
Previous CRA experience is highly desirable.
Previous CRO experience is required.
Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements.
Prior experience in electronic data capture preferred.
Fluent in English.
Proficiency in Microsoft Office (e.g. Word, Excel, Outlook).
The Application Process:
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice:
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!
Our Company Ethos:
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
Key words:
Senior Project Manager, Senior Clinical Project Manager, Senior Study Manager, Study Management, Project Management, Medical Devices, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Study Management, Project Leader, Project Lead, complex clinical trials, oncology, respiratory, CRO, Contract Research Organization
#J-18808-Ljbffr