Project Director / Sr. Project Director

at

Ergomed

Raleigh, NC
Full Time
10mo ago

Company Description

Ergomed is a rapidly growing  global clinical research organization.  We perform clinical trials for rare and complex diseases. Ergomed Plc is a public company on the London stock exchange. The company boasted 40% growth in revenues in its last report.  This success is due to the hard work of our highly skilled employees and our subsequent  reputation for excellence with our clients. 

Job Description

SUMMARY

The Project Director (PD) oversees and directs a portfolio or program of multiple clinical trials, in accordance with Ergomed or Sponsor Standard Operating Procedures (SOPs) as applicable, federal and local regulations, ICH-GCP guidelines, and contracted parameters. The PD manages assigned Sponsor relationships and expectations and collaborates with key stakeholders to drive consistent and strategic program/project management. The PD serves as a point of escalation for Sponsors, vendors, and Project Team members, and is accountable for contractual deliverables, ensuring project/program objectives are achieved on time, within budget, and as per defined quality standards. 

 DUTIES AND RESPONSIBILITIES

  • Oversees and directs project management of a portfolio or program of multiple clinical trials, Phases I-IV, for investigational new drugs and/or devices; may direct clinical programs for a single product and/or Sponsor 

  • Facilitates communications, driving project/program consistencies and lessons learned across national and international Project Teams 

  • Manages relationships and expectations of multiple assigned Sponsors, hosting routine Sponsor meetings; may serve as key member of governance or oversight committees 

  • Supervises project delivery, assisting project management staff in leading full-scope cross-functional Project Teams, overseeing day-to-day operations, to achieve project/program objectives and deliverables 

  • Provides project management coverage as required 

  • Serves as the point of escalation for all project/program stakeholders, including the Sponsor, Project Team, and vendors  

  • Reviews and oversees project contracts and finances, including budgets, invoicing, revenue forecasting, financial analysis, changes in scope, and contract amendments  

  • Accountable for project profitability; analyzes budget overrun variance to determine required actions in collaboration with project management staff 

  • Accountable for proper resource forecasting, allocation, and utilization for assigned projects/programs in collaboration with project management staff; identifies and manages potential resourcing conflicts 

  • Assists in the development and evaluation of Key Performance Indicators (KPIs) throughout the trial  

  • Reviews project/program status updates and reports to assess project performance in accordance with quality standards and contracted parameters 

  • Assists with vendor management, providing oversight of contracted deliverables and parameters 

  • Assists in developing and managing the project timeline; ensures proper tracking of milestones  

  • Oversees the development and implementation of study plans and manuals, across functional areas  

  • Reviews and provides feedback on clinical trial documents as needed 

  • May develop project/program training materials 

  • Assists in performing risk management, including identifying and evaluating potential risks and mitigation strategies; oversees implementation of risk responses  

  • Oversees documentation and escalation of project and quality issues; assists in initiating and conducting corrective/preventive actions as required 

  • Collaborates with Business Development and Proposal Leads on new opportunities; serves as the Operational Lead in developing proposals, budgets, and operational strategies; participates in bid defense meetings 

  • Provides line management of APMs, PMs, and Sr. PMs 

  • Participates in the development and implementation of departmental goals, objectives, and procedures; recommends process improvements to enhance operations  

  • Supports study-specific audits and inspections, acting as a Subject Matter Expert (SME)  

  • Represents Ergomed as a presenter or delegate at professional meetings or seminars

KNOWLEDGE AND SKILLS

  • Thorough understanding of drug and medical device development process, including global regulatory guidelines and ICH-GCP guidelines for the conduct of clinical trials in human subjects   

  • Working knowledge of all clinical trial functional areas, including site feasibility and selection, study start-up and regulatory affairs, clinical monitoring, drug safety/pharmacovigilance, medical monitoring, data management and biostatistics, clinical records, medical writing, and third-party vendors 

  • Excellent organizational skills with strong attention to detail, precision, and accuracy  

  • Excellent English oral and written communication skills  

  • Strong interpersonal and leadership skills, with the ability to communicate and interact competently and professionally at all levels within a complex clinical research environment (both verbal and written) 

  • Strong customer/client relationship management skills  

  • Ability to develop and deliver presentations confidently 

  • Strong ability to manage multiple tasks simultaneously, proactively problem-solve, and manage competing priorities  

  • Ability to make decisions in a timely and appropriate manner  

  • Ability to work independently; is a self-starter  

  • Ability to meet rigorous timelines and work effectively and efficiently in stressful situations  

  • Ability to identify and resolve complex challenges  

  • Ability to analyze and interpret data and prepare evaluative summary reports  

  • Ability to develop and implement clinical research study plans and standard operating procedures  

  • Ability to analyze protocols and develop successful operational strategies, applying lessons learned 

  • Ability to manage, review, evaluate, and report financial aspects of a project/program  

  • Ability to analyze protocols and develop projected enrollment rates and timelines for business development proposals 

  • Ability to motivate, develop, and manage staff performance; Excellent coaching and mentoring skills 

  • Excellent computer skills, including proficiency in MS Office (Word, Excel, PowerPoint, Office, Project)  

TRAVEL

  • Ability to travel approximately 20% both domestically and internationally  

  • Must possess a valid driver’s license and passport 

Qualifications

  • 4-year degree or RN degree from an accredited college or university in a scientific, health, or other related field, or a combination of equivalent education/experience  

  • Minimum of 10 years clinical research industry experience  

  • Minimum of 5 years project management and vendor management experience in full-scope (all functional services), projects, startup to closure, in a pharmaceutical, biotechnology, or CRO environment. Other relevant experience will be considered. 

  • Business development experience, including review of proposals, budgets, and bid defense meeting participation required 

  • Personnel management experience, including performance review, time management, and resource allocation required 

  • Prior site monitoring experience preferred

Additional Information

All of your information will be kept confidential according to EEO guidelines. We are an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

 

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