Senior Project Manager - Remote

  • Raleigh, NC, USA
  • Employees can work remotely
  • Full-time

Company Description

Founded in 1997 by a  Medical Doctors , Ergomed Plc is dedicated to the development of new drugs to save or improve lives. Operating with a global footprint in over 55 countries, Ergomed has the expertise to manage even the most challenging clinical trials.  Ergomed provides services to over 100 clients in a range of therapy areas but excels in the provision of services for  complex trials in Rare Diseases, Oncology and Neuroscience.

Job Description

SUMMARY:

The Senior Project Manager (Sr. PM) is responsible for all phases of clinical trial project management from initiation through closure, in accordance with Ergomed or Sponsor Standard Operating Procedures (SOPs) as applicable, local regulations, ICH-GCP guidelines, and contracted parameters. 

The Sr. PM is responsible for the day-to-day procedural leadership and administrative oversight of a cross-functional project team conducting a clinical research trial, 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. 

The PM is accountable for contractual deliverables, ensuring project objectives are achieved on time, within budget, and as per defined quality standards. 

DUTIES AND RESPONSIBILITIES:

  • Manages assigned clinical trials, Phases I-IV, for investigational new drugs and/or devices

  • May manage clinical trial programs, including multiple trials with a single product and/or Sponsor

  • Oversees Project Managers (PMs) and/or Associate Project Managers (APMs) supporting large clinical trials; may be assigned as a Global PM, overseeing regional PMs, on global trials

  • Leads full-scope cross-functional Project Teams, overseeing day-to-day operations, to achieve project objectives and deliverables

  • Serves as the primary contact for all project stakeholders, including the Sponsor, Project Team, and vendors

  • Manages project contracts and finances, including budgets, invoicing, revenue forecasting, financial analysis, timesheet and expense review, changes in scope, and contract amendments

  • Accountable for project profitability

  • Oversees proper resource allocation and utilization for assigned project(s)

  • Participates in the selection and contracting of vendors

  • Manages vendors, providing oversight of contracted deliverables and parameters

  • Manages relationships and expectations of multiple Sponsors

  • Provides oversight of and drives project communications across functional areas, including regular status updates, project tracking, and project reporting

  • Performs action item tracking and management

  • Plans and hosts internal and external Project Team meetings

  • Collaborates with the Sponsor and Functional Leads to develop and evaluate Key Performance Indicators (KPIs) throughout the trial

  • Develops and manages the project timeline, forecasting and tracking milestones

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

  • Oversees the development, maintenance, and final transfer of the electronic Trial Master File (eTMF)

  • Reviews and provides feedback on clinical trial protocols, Informed Consent Form (ICF) templates, Case Report Forms (CRFs), Clinical Study Report (CSR), and other clinical trial documents

  • Oversees IRB/IEC and regulatory submissions

  • Oversees Project Team training and tracking of training documentation

  • Performs risk management, including identifying, tracking, and evaluating potential risks and mitigation strategies; maintains risk log and implements risk responses

  • Documents and escalates project and quality issues; initiates and conducts corrective/preventive actions as required

  • Oversees clinical supplies and Investigational Product (IP) management

  • Oversees protocol deviation management, including tracking and routine review

  • Oversees study accrual, including cohort management and dose escalation, as applicable

  • Oversees clinical monitoring and site management on assigned project(s); reviews monitoring visit reports as required

  • Oversees development of site-facing materials

  • Plans, develops, and conducts presentations for study site meetings, including Investigator Meetings

  • Participates in the development of site budget templates and reviews site invoices where required

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

  • Submits internal reports and deliverables and attends departmental meetings

  • Mentors APMs, PMs, and other Clinical Operations personnel, providing leadership oversight and motivation

  • Contributes to performance evaluations for project team members

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

  • Collaborates with Business Development and Proposal Leads on new opportunities, including proposal development and bid defense meetings

  • Other related duties, as assigned

 

Qualifications

MINIMUM JOB REQUIREMENTS / 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 8 years clinical research industry experience

  • Minimum of 4 years experience in full-scope project management in a pharmaceutical, biotechnology, or CRO environment

  • Prior site monitoring experience preferred

  • Personnel management experience, including time management and resource allocation preferred

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

  • Knowledge of scientific experimental design and methodology and protocol development 

  • Knowledge of the principles and methods of basic medical and/or clinical research 

  • Knowledge of global regulatory guidelines and ICH-GCP guidelines for the conduct of clinical trials in human subjects 

  • Thorough understanding of drug and medical device development process 

  • 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) while aware of cultural diversity 

  • Good customer/client relationship management skills 

  • Ability to develop and deliver presentations 

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

  • Adapts easily to change 

  • Ability to make decisions in a timely and appropriate manner 

  • Ability to work independently; is a self-starter 

  • Results-driven 

  • 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 manage, review, evaluate, and report financial aspects of a project 

  • Ability to motivate, develop, and manage staff performance in a matrix environment 

  • Ability to provide technical leadership, guidance, and direction to all levels of staff 

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

Additional Information

Our Offer:

  • Competitive salary
  • Dynamic team of colleagues in a fast-growing company – possibility for your quick career growth
  • Multicultural environment, English as a company language
  • Strong emphasis on personal and professional growth
  • Working in a young and friendly team
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