Project Director / Sr. Project Director (Rare Disease)

Job Description

SUMMARY

The Project Director (PD)oversees and directsa portfolio or program of multipleclinical 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 andcollaborateswith key stakeholders to drive consistent and strategic program/project management.The PDserves as a point of escalation for Sponsors, vendors, andProjectTeam members, and is accountable for contractual deliverables, ensuring project/programobjectives are achieved on time, within budget, and as per defined quality standards.

 DUTIES AND RESPONSIBILITIES

• Overseesand directsproject management ofa portfolio or program ofmultipleclinical trials, Phases I-IV, for investigational new drugs and/or devices;maydirectclinicalprogramsfora single product and/or Sponsor

• Facilitates communications, driving project/programconsistencies and lessons learnedacross national and international Project Teams

• Manages relationshipsand expectations of multipleassignedSponsors, hostingroutineSponsormeetings; may serve as key member of governance or oversight committees

• Supervises project delivery, assistingproject management staffin 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 thepoint of escalationfor all project/programstakeholders, including the Sponsor, Project Team, and vendors

• Reviewsand overseesproject contracts and finances, including budgets, invoicing, revenue forecasting, financial analysis, changes in scope, and contract amendments

• Accountable for project profitability;analyzesbudgetoverrunvariance to determine required actionsin collaboration with project management staff

• Accountable forproper resourceforecasting,allocation,and utilization for assigned projects/programsin collaboration with project management staff; identifies and manages potential resourcing conflicts

• Assists in the developmentand evaluation ofKey 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

• Assistsin developing andmanagingthe project timeline; ensures proper tracking ofmilestones

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

• Reviews and provides feedback on clinical trial documentsas needed

• May developproject/programtrainingmaterials

• Assists in performingrisk management, including identifyingand evaluating potential risks and mitigation strategies;oversees implementation ofrisk responses

• Oversees documentation andescalation ofproject and quality issues;assists ininitiatingand conductingcorrective/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 managementof 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 auditsandinspections, acting as a Subject Matter Expert (SME)

• RepresentsErgomedas a presenter or delegate at professional meetings or seminars

KNOWLEDGE AND SKILLS

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

• Working knowledge of allclinical trialfunctional 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 

• ExcellentEnglish oraland 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)

• Strongcustomer/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 licenseandpassport

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 of5yearsproject management and vendor managementexperience infull-scope(all functional services),projects,startup to closure,in a pharmaceutical, biotechnology, or CRO environment. Other relevant experience will be considered.

• Business development experience, includingreview ofproposals, budgets, and bid defense meetingparticipationrequired

• Personnel management experience, including performance review, time management,andresource allocationrequired

• Prior site monitoring experience preferred

Additional Information

All of your information will be kept confidential according to EEO guidelines.We are anequal opportunityemployer. All applicants will be considered foremploymentwithout attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.