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Manager/Sr. Manager of Clinical Operations

Job Description

Our client is looking for a highly motivated Clinical Project Manager. This is a position requiring solid understanding of all aspects of industry sponsored clinical trials Phases 1/2. Individuals suited for this position are highly independent, organized, dedicated to their programs and motivated by achieving organizational goals. Our client is a fast-paced bio-technology company within the Montgomery County area.

* Provide matrix management of functional area representatives to cross-functional teams
* Lead/oversee cross-functional CTTs for early phase studies
* Define and manage accountabilities for all CTT members
* Collaborate with cross-functional area heads to ensure proper resourcing for assigned trials
* Support development of Protocol Concept Sheet (PCS) and Clinical Study Protocol (CSP)
* Develop outsourcing specs for vendor requests for proposal and scope of work agreements
* Manage selection of study vendors for assigned studies
* Manage the vendor(s) throughout the life of assigned clinical trial
* Provide input on investigational site selection in collaboration with Clinical Development and vendors
* Review and refine Clinical Operations Plans/Vendor Oversight Plans
* Provide oversight of monitoring activities through review of monitoring reports, QA-GCP audit reports and communications with investigators, study site personnel and CRAs
* Lead ongoing review of data to ensure quality and consistency
* Participate in planning and conduct of investigator meetings and ad boards, etc.
* Develops and manage program budget(s) and oversees site agreement/budget negotiation process, and manage program timelines
* Oversee the submission of trial-related and essential documents to the Trial Master File
* Identify and provide solutions to clinical trial issues or risks
* Provide input into non-project related activities and development of procedures/SOPs
* Facilitate training to clinical study teams on protocol specific topics
* Participate as appropriate in internal and external audits




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 $999,999.00 /Year
Store Type Biotech, Pharmaceutical, Research
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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:
$999,999.00 /Year
Pay Rate:
Biotech, Pharmaceutical, Research
Store Type:

Job Description

Our client is looking for a highly motivated Clinical Project Manager. This is a position requiring solid understanding of all aspects of industry sponsored clinical trials Phases 1/2. Individuals suited for this position are highly independent, organized, dedicated to their programs and motivated by achieving organizational goals. Our client is a fast-paced bio-technology company within the Montgomery County area.

* Provide matrix management of functional area representatives to cross-functional teams
* Lead/oversee cross-functional CTTs for early phase studies
* Define and manage accountabilities for all CTT members
* Collaborate with cross-functional area heads to ensure proper resourcing for assigned trials
* Support development of Protocol Concept Sheet (PCS) and Clinical Study Protocol (CSP)
* Develop outsourcing specs for vendor requests for proposal and scope of work agreements
* Manage selection of study vendors for assigned studies
* Manage the vendor(s) throughout the life of assigned clinical trial
* Provide input on investigational site selection in collaboration with Clinical Development and vendors
* Review and refine Clinical Operations Plans/Vendor Oversight Plans
* Provide oversight of monitoring activities through review of monitoring reports, QA-GCP audit reports and communications with investigators, study site personnel and CRAs
* Lead ongoing review of data to ensure quality and consistency
* Participate in planning and conduct of investigator meetings and ad boards, etc.
* Develops and manage program budget(s) and oversees site agreement/budget negotiation process, and manage program timelines
* Oversee the submission of trial-related and essential documents to the Trial Master File
* Identify and provide solutions to clinical trial issues or risks
* Provide input into non-project related activities and development of procedures/SOPs
* Facilitate training to clinical study teams on protocol specific topics
* Participate as appropriate in internal and external audits




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

 
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Manager/Sr. Manager of Clinical Operations Apply now