Project Manager, EP

Requisition Number: 1420

Position Title: Project Manager EP

External Description:

SUMMARY: The Project Manager (PM) will manage multiple (8-10) Phase I through II clinical trials that may be local, regional, or global in scope. Worldwide Clinical Trials Project Managers are 100% accountable for the success of their projects:

RESPONSIBILITIES:
Tasks may include but are not limited to:

• Serve as the primary point of contact for sponsor companies throughout the project lifecycle
• Lead core project team and provides oversight
• Proactively manage phase 1 project-level operational aspects of the project team including management of trial timelines, budgets, resources, and vendors
• Leads the study start-up process including the conduct of the trial kick-off meeting, oversight of site(s) startup, set-up of the trial master file (TMF), and assistance with vendor selection.
• Ensure project plans are in place before first study dosing including authoring plans such as the project management plan and communication plan
• Leads regularly scheduled cross-functional study team meetings with internal and external resources
• Define and manage project resource needs in conjunction with functional group leads
• Ensure potential study risks are identified and mitigation strategies are implemented
• Reviews trial-related documents
• Leads site initiation visits
• Ensure GCP and regulatory compliance is maintained
• Oversight of site(s) during clinical conduct
• Track clinical monitoring visit reports including follow-up and resolution of site(s) issues
• Monitor the quality of vendor deliverables including sites subcontracted by Worldwide Clinical Trials
• Ensure appropriate communication with project stakeholders both internally and externally
• Ensure project deliverables are met according to Worldwide Clinical Trials and sponsor expectations
• Ensure all project-level study documentation is filed in the trial master file (TMF)
• Perform QC and reconciliation of the trial master file (TMF)
• Liaise with functional group management in the identification of any training of development needs
• Ensure that all staff allocated to assigned projects is trained on the study protocol and all other study-related processes, including SOPs
• Review and approve invoices and collaborate with accounts payable
• Track monthly project financials and report revenue recognition
• Assist with financial audits
• Review out of scope work and capture change orders for projects
• Responsible for achieving revenue and margin goals
• Liaise and build rapport with sponsors to ensure client retention and profitability
• Responsible for tracking and delivering project metrics
• Assist business development during the awards process by attending sponsor visits and bid defense meetings
• Provide support to business development and address technical or project-related questions
• Responsible for governance
• Participates or leads operating committees or steering committees
• Assists with sponsor and/or regulatory audits
• Provides training and mentorship for clinical trial associates
• Perform other duties as assigned by management

 
The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

 

OTHER SKILLS AND ABILITIES:

• Experience in managing multiple phase 1 projects in a multi-office environment
• Demonstrated ability to handle multiple competing priorities; utilize resources effectively
• Demonstrated ability to inspire effective teamwork and motivate team members
• Demonstrated ability to lead by example and to encourage team members to seek solutions
• Excellent communication, planning, and organizational skills
• Self-motivated and excellent problem-solving skills
• Strong interpersonal skills
• Ability to work independently
• Ability to liaise with clients in a professional manner
• Good computer skills

REQUIREMENTS:  

• University/college degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology) or equivalent combination of education and experience that provides the individual with the required knowledge, skills, and abilities
• Minimum of five (5) years of clinical pharmaceutical industry experience including demonstrated skills and competency in clinical project management tasks
• In lieu of the above requirements, candidates with > five (5) years supervisory experience in a health care setting and four (4) years of clinical research experience in the pharmaceutical or CRO industries will be considered and/or proven ability and demonstration of relevant experience and skills in clinical development
• Thorough knowledge of project management processes
• Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
• Available for domestic and international travel, including overnight stays Valid current passport, required
• Ability to drive and have a valid driver’s license
• Fluent in English, both written and verbal
• Broad knowledge of drug development process and client needs

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City:

State: North Carolina

Employment Type: Regular

Community / Marketing Title: Project Manager, EP

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

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