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.
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
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)
Our Offer:
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