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Therapeutic Area Project Manager

Job Description

Must Haves:
5 years of Clinical Trial / Project Management in Drug Development
4+ CRO or Vendor oversight for Global Studies
Experience managing clinical Study Budgets and essential regulatory documents (CRFs, TMF, IRB documents)
4 Year degree required (MS Preferred)

SUMMARY: The Project Manager provides project management leadership for the cross functional clinical development teams, ensuring deliverables are met on time, within budget and in accordance with quality expectations. For the assigned therapeutic area(s), they support the planning of the clinical strategy, develop and monitor the clinical program budget and timelines against the baseline. Facilitates strategic planning and decision-making, drive activities to completion, troubleshoots issues, and identifies/manages risks within the clinical program and with external partners, as appropriate.

JOB RESPONSIBILITIES:
* Teams: Guides and facilitates the clinical development team to plan and execute the clinical program's goals for the assigned assets within a therapeutic areas. Coordinates and drives the clinical strategy to completion across the various development phases (e.g. pre-IND to life cycle management) within scope, timelines and budget.

* Communication and Collaboration: Manages the clinical program interactions to ensure that the cross-functional teams are aligned on the deliverables and successfully set up to execute. Fosters a productive and positive team environment and collaborates closely with the development program manager, operations lead and clinical development lead. Liaises between the strategic development team and the clinical development team to communicate relevant and contemporaneous inputs/outputs from each team. Effectively facilitates the clinical development team meetings and translates the strategic clinical goals into operational plans. For collaborator programs, will act as the conduit to provide status reports on internal clinical and operational activities.

* Planning: Drives the discussions related to early planning to develop the studies that will form the clinical development plan and integrated clinical timelines. Facilitates the protocol expanded synopsis process from collection of early assumptions to document finalization with associated budget and timelines. Collaborates with clinical logistics to provide assumptions for early drug supply planning. Plan and monitor the clinical deliverables required for regulatory submissions (e.g. IND, CTA, BLA, MAA, etc.)

* Project Reporting and Tracking: Maintains knowledge of key clinical data and milestones for assigned projects and serves as the primary contact for information and updates. Provides project summaries and general guidelines to support presentations to senior management and collaborators as needed.

* Budgets and Timelines: Participates in scenario planning to provide management with decision-making information, such as high-level timelines and costs. Coordinates with the cross-functional team and gains alignment on the assumptions that will drive the initial budget and timelines. Accountable for the budget development process and facilitates the budget approval process with the clinical study team. Participates in the quarterly reforecast cycle to ensure the clinical assumptions are current and accurate within the operational development plan documents. Oversees clinical study timelines and performs ongoing assessment of current timelines against the baseline.

* Process Improvement: May participate in workstreams, initiatives and review functional Standard Operating Procedures (SOPs) within the Global Development organization

* Problem Solving and Risk Identification: Identifies risks and develops/manages mitigation strategies. Facilitates action follow-up and issue resolution within the matrix-environment of the clinical development team in order to deliver against project goals. Leads and participates in Lessons Learned debriefs.




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-NY-Tarrytown
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type 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-NY-Tarrytown
Samira Chowdhury
9738294433
Snapshot
Aerotek
Company:
US-NY-Tarrytown
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Research
Store Type:

Job Description

Must Haves:
5 years of Clinical Trial / Project Management in Drug Development
4+ CRO or Vendor oversight for Global Studies
Experience managing clinical Study Budgets and essential regulatory documents (CRFs, TMF, IRB documents)
4 Year degree required (MS Preferred)

SUMMARY: The Project Manager provides project management leadership for the cross functional clinical development teams, ensuring deliverables are met on time, within budget and in accordance with quality expectations. For the assigned therapeutic area(s), they support the planning of the clinical strategy, develop and monitor the clinical program budget and timelines against the baseline. Facilitates strategic planning and decision-making, drive activities to completion, troubleshoots issues, and identifies/manages risks within the clinical program and with external partners, as appropriate.

JOB RESPONSIBILITIES:
* Teams: Guides and facilitates the clinical development team to plan and execute the clinical program's goals for the assigned assets within a therapeutic areas. Coordinates and drives the clinical strategy to completion across the various development phases (e.g. pre-IND to life cycle management) within scope, timelines and budget.

* Communication and Collaboration: Manages the clinical program interactions to ensure that the cross-functional teams are aligned on the deliverables and successfully set up to execute. Fosters a productive and positive team environment and collaborates closely with the development program manager, operations lead and clinical development lead. Liaises between the strategic development team and the clinical development team to communicate relevant and contemporaneous inputs/outputs from each team. Effectively facilitates the clinical development team meetings and translates the strategic clinical goals into operational plans. For collaborator programs, will act as the conduit to provide status reports on internal clinical and operational activities.

* Planning: Drives the discussions related to early planning to develop the studies that will form the clinical development plan and integrated clinical timelines. Facilitates the protocol expanded synopsis process from collection of early assumptions to document finalization with associated budget and timelines. Collaborates with clinical logistics to provide assumptions for early drug supply planning. Plan and monitor the clinical deliverables required for regulatory submissions (e.g. IND, CTA, BLA, MAA, etc.)

* Project Reporting and Tracking: Maintains knowledge of key clinical data and milestones for assigned projects and serves as the primary contact for information and updates. Provides project summaries and general guidelines to support presentations to senior management and collaborators as needed.

* Budgets and Timelines: Participates in scenario planning to provide management with decision-making information, such as high-level timelines and costs. Coordinates with the cross-functional team and gains alignment on the assumptions that will drive the initial budget and timelines. Accountable for the budget development process and facilitates the budget approval process with the clinical study team. Participates in the quarterly reforecast cycle to ensure the clinical assumptions are current and accurate within the operational development plan documents. Oversees clinical study timelines and performs ongoing assessment of current timelines against the baseline.

* Process Improvement: May participate in workstreams, initiatives and review functional Standard Operating Procedures (SOPs) within the Global Development organization

* Problem Solving and Risk Identification: Identifies risks and develops/manages mitigation strategies. Facilitates action follow-up and issue resolution within the matrix-environment of the clinical development team in order to deliver against project goals. Leads and participates in Lessons Learned debriefs.




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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