Global Project Director
Premier Research - Florida

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The Project Director (PD) is the senior liaison with and has overall responsibility for assigned customers and is the primary point of contact for clinical programs.The primary function of the Project Director is to oversee and direct multiple clinical trials concurrently. The Project Director leads and directs global cross-functional teams and manages client expectations to achieve client satisfaction. The Project Director proactively identifies, resolves/mitigates and escalates risks and/or issues. The Project Director may be required to manage large national, international and/or particularly complex, projects or programs. The Project Director oversees the Project Managers and Project Associates assigned to his/her clinical program.


The Project Director:
Ensures successful management and coordination of efforts assigned to members of the global project team, including Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety, to support milestone achievement and overall program delivery

Ensures adherence to program budget and scope of work to realize program profitability

Ensures all program tasks are completed in accordance with program plans and in compliance with standard Premier Research processes, policies and procedures

Ensures effective communication is maintained and program status reports and monthly progress reports are provided both internally and externally

Ensure adequate resourcing is available to meet program deliverables and milestones


For project success:
Acts as the key relationship manager between Premier Research and the customer

Oversees and/or managesthe program team to ensure program progress is according to client and Premier Research requirements and recommends and drives necessary courses of action to keep program on track

Facilitates team training in accordance with protocol and/or program requirements, including therapeutic, protocol specific, and process training

Supervise and assess the performance of the core team members and motivate, train and develop the team's expertise to ensure efficient and effective day-to-day operations

Facilitates communication within the program and cross functional teams

Evaluates program progress based on company tracking systems, program timelines and budget reviews provided by Project Management staff

Provides program progress reports including team performance against contract, customer expectations, and project baselines

Monitors the quality of program deliverables and address quality issues with the appropriate team members

Facilitates resolution of program related conflicts with necessary corrective action and alerts senior management to potential issues

Continually reviews and makes recommendations to ensure adequate resources are available to meet program deliverables and milestones

Reviews study audit finding and provides corrective action

For commercial success:
Monitors and manages customer satisfaction

Assists in the creation, development and nurturing of key strategic customer relationships

Prepares forecasts for staff utilization over the life of the program

Ensures all study related contractual and budgeting issues are upheld and performed

Provides accurate forecasts to ensure timely invoicing

Supports program team in identifying scope of work changes across all functional areas and secures Change Orders

Assists in Business Development activities including proposal development, proposal costing and budget reviews, and leading proposal presentations in partnership with Business Development and Scientific Account Leadership

Ensures appropriate transition planning and stakeholder communication for any change in staff

Recruits and manages the business relationship with central vendors as required per program scope

Provides performance feedback on program team members for annual appraisals

Mentors and trains Senior Project Managers and Project Managers

Participates in function and/or corporate initiatives, special assignments, and as a customer liaison or departmental cross-functional liaison

Participates in quality improvements efforts to increase overall operational efficacy

Represents Premier Research as a presenter at professional meetings or seminars

Other activities as designated

Required Skills

Required Experience

1. Educational background

Undergraduate degree in a clinical, biological, scientific, or health-related field

2. Experience

Minimum 8 years relevant experience in a pharmaceutical company/CRO including trial management experience

At least 4 years experience in clinical trial management as a Senior Project Manager

Budget/finance/costing experience on a project level

Experience in coaching/mentoring other PMs

Experience in managing complex, global trials; multiple phases; and full lifecycle

3. Expertise and know-how

Excellent knowledge of ICH/GCP regulations

Strong working knowledge of FDA Guidance Documents/EU Directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures

Excellent knowledge of the principles of project management

Excellent knowledge of full service functional areas

Strong knowledge of web based communication tools for conferences

Highly confident and effective presenter

Strong software and computer skills, including MS Office applications

Strong financial acumen

Commercial and organizational expertise

4. Personal skills & behaviors

Full-time availability to internal and external project team members

Fluent verbal and written English

Excellent verbal and written communication skills

Organizational leadership and motivational skills

Strong customer relationship building skills

Excellent team player

Ability to balance operational and strategic priorities

Proactive management skills

Cross cultural awareness

Ability to interact and present to Senior Management

Excellent organizational and time-management skills, able to meet deadlines

Ability to work autonomously with minimal guidance for study execution

Accountable, dependable and strong commitment

Applies clear and consistent performance standards and handles problems decisively and objectively

Is customer service focused in approach to work both internally and externally

Maintains a positive, results orientated work environment

Willingness to travel

Premier Research - 23 months ago - save job
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