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Senior Clinical Project Manager

Job Description

I am actively recruiting on an immediate full time SENIOR CLINICAL PROJECT MANAGER position.

The Senior Project Manager will provide support to clinical development operations, trial strategy and project management. All oncology studies (advanced solid tumor,rare cancer/disease)

This individual will facilitate the cross functional preparation, implementation and facilitation of projects related to clinical trials in the US and around the world.

The Senior Project Manager will plan and manage projects or sub-projects under the general direction of the department director.

Essential Functions:

* The Project Manager will also assist with various project activities, supporting clinical project (phase 1-4 clinical trial programs) initiation, budgeting, planning, execution and completion, which may include clinical project schedules, process development and budgets, tracking, status reporting, project communication, information gathering, coordination and facilitation of meetings, tracking and resolution of issues, and tracking risks and resources and applicable global regulations and ICH/GCP guidelines

* Chair team meetings for assigned projects ensuring goals and deliverables are clearly defined, and issues, decisions, risks and action items are appropriately tracked.

* Provide leadership, guidance, global clinical trial expertise and direction to internal and external project teams to ensure process consistency and knowledge sharing.

* Develop project level budgets and timelines based on project and global business needs.

* Manage vendors/CROs and functional contractors. Lead vendor selection for assigned projects. Oversee vendor management for assigned projects, including negotiation of scope of work, budgets, performance management and issue resolution.

* Assess current and projected demands of a clinical study or program, and partner with department head and leadership to identify and secure resources.

* Analyze and develop action plans for investigational site, vendor and administrative issues.

* In collaboration with the Medical Director, analyze, develop action plans and escalate safety issues, patient care issues, and study design and/or conduct issues.

* Plan, prepare and present at investigator meetings.

* Oversee and contribute to development of key study documents including, but not limited to study protocols, protocol amendments, study plans and procedure manuals, project tools, informed consent forms and clinical study reports. Contribute to development of the compound/project clinical development plan.

* Evaluate, manage and facilitate the timely flow of clinical data to support project objectives.

* Oversee forecasts to maintain sufficient clinical and non-clinical supplies.

* Prepare and present study or project specific updates.

* Represent Project Management & Clinical Operations in partnered development programs.

* Participate in or lead process development initiatives, as required.

Qualifications:

  • Bachelor's Degree (scientific or medical discipline preferred). Graduate degree is a plus.
  • A minimum of at least 9 years of relevant pharmaceutical development experience including at least 5 years of clinical project management in the pharmaceutical industry
  • Applied knowledge of FDA regulations and ICH GCP guidelines
  • Ability to manage projects and lead study team(s) with minimum supervision, deal with ambiguity, multitask and maintain tight timelines and priorities in a highly professional manner
  • Experience in vendor oversight and managing contractors to deliver desired outcomes
  • Fluent in MS Project, Excel, PowerPoint and Word tools
  • Demonstrated ability to lead a team and to be an adaptable and solution oriented team player
  • Experience working with multi-disciplinary cross-cultural teams in a matrix environment
  • Experience developing study and program execution strategies and risk mitigation
  • Travel Estimate: up to 10%




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 [email protected] .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-NJ-Princeton
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type Biotech, Health Care, Pharmaceutical
Other Compensation: Based on Experience
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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-NJ-Princeton
Christian Spaanstra
7324471198
Snapshot
Aerotek
Company:
US-NJ-Princeton
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Biotech, Health Care, Pharmaceutical
Store Type:

Job Description

I am actively recruiting on an immediate full time SENIOR CLINICAL PROJECT MANAGER position.

The Senior Project Manager will provide support to clinical development operations, trial strategy and project management. All oncology studies (advanced solid tumor,rare cancer/disease)

This individual will facilitate the cross functional preparation, implementation and facilitation of projects related to clinical trials in the US and around the world.

The Senior Project Manager will plan and manage projects or sub-projects under the general direction of the department director.

Essential Functions:

* The Project Manager will also assist with various project activities, supporting clinical project (phase 1-4 clinical trial programs) initiation, budgeting, planning, execution and completion, which may include clinical project schedules, process development and budgets, tracking, status reporting, project communication, information gathering, coordination and facilitation of meetings, tracking and resolution of issues, and tracking risks and resources and applicable global regulations and ICH/GCP guidelines

* Chair team meetings for assigned projects ensuring goals and deliverables are clearly defined, and issues, decisions, risks and action items are appropriately tracked.

* Provide leadership, guidance, global clinical trial expertise and direction to internal and external project teams to ensure process consistency and knowledge sharing.

* Develop project level budgets and timelines based on project and global business needs.

* Manage vendors/CROs and functional contractors. Lead vendor selection for assigned projects. Oversee vendor management for assigned projects, including negotiation of scope of work, budgets, performance management and issue resolution.

* Assess current and projected demands of a clinical study or program, and partner with department head and leadership to identify and secure resources.

* Analyze and develop action plans for investigational site, vendor and administrative issues.

* In collaboration with the Medical Director, analyze, develop action plans and escalate safety issues, patient care issues, and study design and/or conduct issues.

* Plan, prepare and present at investigator meetings.

* Oversee and contribute to development of key study documents including, but not limited to study protocols, protocol amendments, study plans and procedure manuals, project tools, informed consent forms and clinical study reports. Contribute to development of the compound/project clinical development plan.

* Evaluate, manage and facilitate the timely flow of clinical data to support project objectives.

* Oversee forecasts to maintain sufficient clinical and non-clinical supplies.

* Prepare and present study or project specific updates.

* Represent Project Management & Clinical Operations in partnered development programs.

* Participate in or lead process development initiatives, as required.

Qualifications:

  • Bachelor's Degree (scientific or medical discipline preferred). Graduate degree is a plus.
  • A minimum of at least 9 years of relevant pharmaceutical development experience including at least 5 years of clinical project management in the pharmaceutical industry
  • Applied knowledge of FDA regulations and ICH GCP guidelines
  • Ability to manage projects and lead study team(s) with minimum supervision, deal with ambiguity, multitask and maintain tight timelines and priorities in a highly professional manner
  • Experience in vendor oversight and managing contractors to deliver desired outcomes
  • Fluent in MS Project, Excel, PowerPoint and Word tools
  • Demonstrated ability to lead a team and to be an adaptable and solution oriented team player
  • Experience working with multi-disciplinary cross-cultural teams in a matrix environment
  • Experience developing study and program execution strategies and risk mitigation
  • Travel Estimate: up to 10%




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 [email protected] .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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