Clinical Project Leader

CLINMARK - CONTRACT RESEARCH AND CONSULTING ORGANIZATION; Warszawa; On-site; PLN 120,000 - 180,000; Full time

Job summary

CLINMARK - CONTRACT RESEARCH AND CONSULTING ORGANIZATION is seeking a skilled CRA to act as the primary sponsor contact and oversee study execution. You will coordinate with international teams and ensure compliance with ICH GCP guidelines.

The role requires strong English communication, analytical abilities, and the capacity to work independently within a collaborative team environment. Prior experience in site management and budgeting is advantageous.

Qualifications

• At least 4 years of experience as CRA (6 years in clinical trials).
• Knowledge of ICH GCP guidelines and applicable regulations.
• Good English speaking and writing abilities.
• Strong analytical and organizational skills.
• Ability to work independently and within a team.

Responsibilities

• Acts as primary contact for Sponsor representative and leads communications.
• Manages and oversees study execution within the company.
• Participates in international project meetings and calls.
• Escalates and resolves issues during the study.
• Reviews site visit reports and submits packages.
• Supervises interactions with EC and RA and QA processes.
• Oversees TMF maintenance and vendor assessments.
• Supports site contracts negotiations and study budgeting.
• Conducts Co-Visits with CRAs and ensures reporting.
• Participates in audit debriefings and CAPA proposals.
• Contributes to SOP development and training organization.

Skills

CRA Experience

Analytical skills

Organizational skills

Communication skills

English proficiency

Team collaboration

Education

MSc or life science degree

Job description

• Acts as primary contact for Sponsor representative (leader in communication with Sponsor)
• Manages and oversight of study execution within the company
• Participates in Project meetings/TCs/calls especially in international area
• Involves in escalation and resolution of issues raised during the course of the study
• Reviews of site visit reports
• Supervises of all kind of contact with EC and RA
• Reviews submission package
• Performs quality assessment of sites monitoring activities
• Supervises of study sites’ management
• Supports for sites contracts negotiation
• Supervises of TMF maintenance
• Translates of study documentation and translation’s independent process supervision
• Manages study budget, Service units and project pass through costs reporting according to the contractual agreement with the client
• Supervises of payments to investigators/institutions
• Collects information on daily/ weekly/monthly basis about project progress
• Reports study progress periodical to HCO
• Self-controls of time and efforts dedicated to particular tasks.
• Prepares summary reporting to HCO with proposal of optimization.
• Introduces metrics driven approach to repeated processes and tasks
• Creates useful tools and trackers to conducted projects and for general use
• Performs Co-Visits (training and supervisory) with CRAs and completion of co-visit report
• Performs Site Assessment Visits in supervised projects
• Participates in audit debriefing, if applicable, and ensure site level response to audits
• Contributes to periodical Vendors’ performance assessment; prepares CAPA proposals
• Involves in Vendors selection process
• Involves in internal SOPs development process
• Involves in training organization (including external)
• Involves in new resources recruitment and operational on-boarding processes

General Requirements

• MSc or equivalent degree, preferably in life science
• Knowledge of ICH GCP Guidelines and all applicable regulations
• At least 4 years of experience as CRA (6 years in clinical trials)
• Good English knowledge in speaking and writing
• Strong analytical skills
• Demonstrate ability to work effectively
• Good organizational and communication skills
• Demonstrate the ability to work independently and within the team
• Ability to create effective and supportive relationships with sponsors/clients