Project Manager II, Early Phase (Romania)

Description

The Project Manager II, EPTR has the overall responsibility for the successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical trials. The Project Manager II, EPTR oversees and coordinates study resources to ensure compliance with the study budget, project scope and timelines and in accordance with applicable standard operating procedures (SOPs), good clinical practices, regulatory and study-specific requirements. The Project Manager II, EPTR acts as the main line of communication to relevant stakeholders and provides input to feasibility, study design, budget development and ensures progress reporting (resources, budget and timeline).

More specifically, the Project Manager II, Early Phase and Translational Research (EPTR):

• Acts as the main point of contact for sponsors, vendors, and internal study teams throughout the lifecycle of a clinical trial.

• Works closely with clients at study start-up to understand their goals and help determine the most effective operational approach.

• Maintains regular communication with sponsors, study teams, functional departments, clinical sites, and senior management.

• Oversees all operational aspects of clinical trials, including timelines, budgets, resources, vendor management, and clinical operations activities, while coordinating deliverables across departments.

• Monitors and controls study budgets by tracking hours, reviewing billed time, identifying out-of-scope activities, and supporting change order management.

• Provides regular updates to internal and external stakeholders on study progress, including site selection, vendor management, budgets, timelines, quality standards, and risk mitigation efforts.

• Leads study start-up activities, including kick-off meetings, Trial Master File (TMF) setup, site selection and activation, vendor onboarding, site contracting, and budget negotiations.

• Identifies and manages risks, implements quality control measures, and escalates issues to management, quality assurance, or sponsors when necessary.

• Leads client meetings, internal team meetings, and vendor status calls, ensuring meeting minutes are documented, distributed, and filed appropriately.

• Oversees the quality of project deliverables, including vendor and subcontractor outputs, and drives continuous improvement in training, execution, and quality processes.

• Evaluates differences between planned and actual project outcomes and implements corrective actions when required.

• Ensures study-specific training matrices are customized, maintained, and up to date.

• Verifies that all team members and service providers receive adequate project training and that training records remain current.

• Reviews and approves responses to quality assurance audits to ensure compliance with company procedures and regulatory requirements.

• Ensures key study documents and deliverables, such as protocols, informed consent forms, eCRFs, source document templates, tables/listings/figures, and clinical study reports, are completed on schedule and meet study requirements.

• Oversees the filing, maintenance, and archiving of study documentation within the TMF in compliance with company SOPs and regulatory requirements.

• Provides project status updates while ensuring compliance with budgets, scope, timelines, SOPs, Good Clinical Practice (GCP), regulatory requirements, and study-specific procedures.

• Tracks recruitment performance and develops mitigation plans when enrollment timelines are at risk.

• Participates in the planning and execution of Investigator Meetings.

• Works with Regulatory Affairs to ensure ethics submissions are completed on time and that essential documents are collected and maintained throughout the study.

• Ensures the TMF remains complete, accurate, and inspection-ready at all times.

• May oversee clinical monitoring activities, including site qualification, initiation, routine monitoring, and close-out visits, as well as CRA training and monitoring oversight.

• Supports study sites and ensures they have the necessary materials and resources to conduct the study effectively.

• Collaborates with Data Management to ensure CRFs meet protocol and sponsor requirements and that data review and query resolution remain on schedule through database lock.

• Partners with Clinical Operations to ensure monitoring activities are completed according to sponsor expectations, SOPs, regulations, GCP, and study requirements.

• Contributes to the development of Clinical Monitoring Plans.

• Provides project-specific training to Clinical Research Associates (CRAs) and may conduct site initiation visits for single-site studies.

• Develops annotated site visit reports and monitoring tools, including source data verification worksheets.

• May mentor junior staff and support the onboarding of new employees.

• Provides technical, therapeutic, and project management expertise to support departmental training and process improvement initiatives.

• May participate in business development activities, including client meetings, proposal defenses, RFIs, and RFP responses.

• May contribute to process improvement initiatives, including the development, testing, and implementation of operational tools and processes.

Requirements

• A Bachelor's degree (B.Sc.) in a field related to clinical research. A Master's degree (M.Sc.) or Ph.D. is considered an asset.

• At least 5 years of experience in the clinical research industry, including a minimum of 3 years of project management experience in Phase I and Phase II clinical trials.

• Experience managing multiple clinical trials simultaneously across several study sites.

• Previous experience in dermatology clinical trials, which is strongly preferred.

• Strong knowledge of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, FDA requirements, and applicable local regulations.

• Proficiency with the Microsoft Office Suite.

• Excellent written and verbal communication skills in English.

• Bilingualism in English and French is highly desirable.

• The ability to work effectively in a collaborative team environment and build strong relationships with colleagues, sponsors, and other stakeholders.

• Strong problem-solving, critical-thinking, and creative-thinking skills.

• Solid scientific understanding and clinical research knowledge.

• Broad cross-functional knowledge of clinical research operations.

• The ability to manage multiple projects, prioritize competing demands, and perform effectively under pressure while meeting deadlines.

• Knowledge of Good Clinical Practices as well as applicable Health Canada and FDA regulations and guidelines.

Our company

The work environment

At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability, and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

In this position, you will be eligible for the following perks:

• Permanent full-time position

• Flexible schedule

• Vacation

• Home-based position

• Ongoing learning and development

About Indero

Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.

Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Indero only accepts applicants who can legally work in Romania.

Originally posted on Himalayas