Global Project Manager
Premier Research - Philadelphia, PA

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POSITION SUMMARY:
Manages projects awarded to Premier Research Group. Oversees and coordinates the operational aspects of assigned project personnel on ongoing projects, and ensures that the client's and internal goals of time, cost, and quality performance are met. Acts as the primary liaison with assigned clients.

PRIMARY JOB FUNCTIONS:
Act as the primary liaison between Premier Research and the client on studies; manages the Project Team, to ensure study progress is according to client and Premier Research requirements; may work on multiple projects simultaneously

Maintains effective communication with client and/or director within Premier Research as required through frequent meetings, teleconferences, written correspondence, and Study Progress Reports

May provide supervision of CTM staff including, but not limited to, performance management (quality, quantity and timeliness of work performed), guidance on corporate policy, training and support

Responsible for the quality, composition and maintenance of the study files for all assigned studies

Ensures completion of all tasks assigned to members of the project team, including Regulatory, Data Management, Biostatistics, QC/QA, Clinical Monitoring, and Medical Affairs/Safety

Maintains working knowledge of assigned Protocols, Case Report Forms, and any other study-related documents; develops a Project Operations Manual and monitors against project progress; ensures project activity compliance with plan; takes corrective action where necessary; provides knowledgeable, demonstrated leadership of all study requirements to Premier Research staff

Maintains and evaluates study progress by using company tracking systems, status reports, site visit scheduling, and project budget review; ensures expected progress and performance are on target throughout the study both at the project team and investigator level

Develops Project Specific Procedures as necessary, with responsible functional areas

Tracks and adheres to project budget and milestones to ensure project profitability; takes corrective measures where necessary to keep project in line with budget and profit expectations; identifies scope of work changes on assigned projects

Co-ordinates and generates contracts with external providers/third party vendors, and investigators, if applicable

Reviews and approves clinical project expenses and ensures all study related contractual and budgeting issues are upheld and performed; oversees and tracks invoicing and site payment issues, as required

Chairs regular project team meeting/teleconferences and facilitates resolution of project related conflicts; facilitates team building and communication within Operations

Provides project progress reports on project activities, as requested

May participate in site selection, and training of investigators to maximize success potential

Works with Clinical Manager to maintain regular communication with CRAs to review overall study progress and to resolve any therapeutic or recruitment issues

Oversees the regulatory document collection and submission process; maintains liaison with QA personnel to ensure a trial is appropriately audited

May accompany CRAs on routine monitoring visits; helps develops an action plan for under-performing sites in conjunction with CRAs

May review site visit reports as per SOP requirements in order to stay current with site issues and CRA performance on studies

May be required to monitor sites for the projects for which they are responsible

Coordinates the data cleanup between Clinical Operations, Data Management, Biostatistics, and Medical Affairs/Safety

Assists in Business Development activities and may attend bid defence meetings where required

Assists in prospective study feasibility assessment, as required

May undertake the functions of a Biometrics Project Manager or Clinical Manager on projects where no such manager is assigned

OTHER RESPONSIBILITIES:
Maintains overall awareness in the field of Clinical Research, as well as assigned therapeutic areas, by reading related literature, attending training classes, attending professional meetings, etc.

To update CV and Training records as necessary and make available for client review where appropriate

Remains alert for new business opportunities, network, and provides information to business development staff or manager

May participate in the development, training and updating of clinical Standard Operating Procedures, Local Working Guidelines and departmental policies

Performs other work-related duties as assigned

Required Skills

Required Experience

EDUCATION/SKILL/EXPERIENCE REQUIREMENTS:
Requires a degree in the life sciences and a minimum of 4 years relevant experience in clinical research, preferably with a minimum of 1 year as a Sr. CRA and/or project lead

Therapeutic indications: Analgesia/Rheumatology, Neurology, Psychiatry, Pediatrics, Infectious Disease, Oncology, General Medicine

Global experience preferred

Knowledge and experience with FDA/ICH or ISO 14155 regulations, drug development. GCP and clinical monitoring procedures are necessary

Requires effective presentation, documentation, interpersonal, decision making and leadership skills, as well as strong team-oriented approach

Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential

Strong computer skills are necessary

A willingness to travel and fluency, both written and oral, in the English language are required

Premier Research - 15 months ago - save job - block
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