The #1 Site for Management Jobs - search all Management jobs.

Clinical Project Manager

Job Description

The Clinical Project Manager is responsible for participating in the planning and execution of specified clinical projects while adhering to budget, scope and timeline requirements and applicable regulations, including FDA and ICH. Responsible for the execution of clinical trial(s) from protocol design to the final clinical study report. Works under general supervision. This project Manager will be responsible for overseeing 2 ongoing or upcoming Phase I-II clinical trials within Oncology.
*Participates in the planning, implementation and management of Phase I- II clinical trials, in collaboration with Contract Research Organization (CRO) partners
*Contributes to development of RFPs and participates in selection of CROs/vendors. Manages CRO and vendor activities to ensure adherence to deliverables and timelines. May train CROs, vendors, investigators, and study coordinators on study requirements
*Actively involved in the execution of a clinical trial(s) from protocol design to the final clinical study report. Contributes to the development of clinical protocols and clinical study reports
*Prepares and/or coordinates review and distribution of relevant documents including but not limited to: informed consent forms, case report forms, laboratory/monitoring plans, monitoring reports
*Participates in the implementation of the operational plans for each [assigned] clinical project. Works closely with external and internal team members to ensure smooth operation and compliance with applicable regulations and FDA/EU/ ICH guidelines
*Maintains and reviews study timelines. Contributes to development of study budget(s)
*Ensures the ongoing compilation and reconciliation of the Trial Master File so that clinical trial(s) is 'audit ready' at all times. Ensures that any audit observations are addressed appropriately and in a timely manner
*May provide leadership and guidance to other clinical operation staff members
*Complies with all applicable policies regarding health, safety, and environmental policies




About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.



The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.

Job Requirements

 

Job Snapshot

Location US-MD-Gaithersburg
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type Biotech, Pharmaceutical, Research
Apply

Company Overview

Aerotek

We know that a company’s success starts with its employees. We also know that an individual’s success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek’s people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has become a leader in recruiting and staffing services by building quality relationships that allow us to place quality people in quality jobs. With more than 230 non-franchised offices, Aerotek’s 6,000 internal employees serve more than 300,000 contract employees and 17,000 clients every year. To learn more, visit Aerotek.com. Learn More

Contact Information

US-MD-Gaithersburg
Nathalie Karam
3012504323
Snapshot
Aerotek
Company:
US-MD-Gaithersburg
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Biotech, Pharmaceutical, Research
Store Type:

Job Description

The Clinical Project Manager is responsible for participating in the planning and execution of specified clinical projects while adhering to budget, scope and timeline requirements and applicable regulations, including FDA and ICH. Responsible for the execution of clinical trial(s) from protocol design to the final clinical study report. Works under general supervision. This project Manager will be responsible for overseeing 2 ongoing or upcoming Phase I-II clinical trials within Oncology.
*Participates in the planning, implementation and management of Phase I- II clinical trials, in collaboration with Contract Research Organization (CRO) partners
*Contributes to development of RFPs and participates in selection of CROs/vendors. Manages CRO and vendor activities to ensure adherence to deliverables and timelines. May train CROs, vendors, investigators, and study coordinators on study requirements
*Actively involved in the execution of a clinical trial(s) from protocol design to the final clinical study report. Contributes to the development of clinical protocols and clinical study reports
*Prepares and/or coordinates review and distribution of relevant documents including but not limited to: informed consent forms, case report forms, laboratory/monitoring plans, monitoring reports
*Participates in the implementation of the operational plans for each [assigned] clinical project. Works closely with external and internal team members to ensure smooth operation and compliance with applicable regulations and FDA/EU/ ICH guidelines
*Maintains and reviews study timelines. Contributes to development of study budget(s)
*Ensures the ongoing compilation and reconciliation of the Trial Master File so that clinical trial(s) is 'audit ready' at all times. Ensures that any audit observations are addressed appropriately and in a timely manner
*May provide leadership and guidance to other clinical operation staff members
*Complies with all applicable policies regarding health, safety, and environmental policies




About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.



The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.

Job Requirements

 
M3p75q66m5p56jwcl8v
HeadHunter Advice

For your privacy and protection, when applying to a job online: Never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction.Learn More

By applying to a job using headhunter.com you are agreeing to comply with and be subject to the workinretail.com Terms and Conditions for use of our website. To use our website, you must agree with theTerms & Conditionsand both meet and comply with their provisions.
Clinical Project Manager Apply now