Clinical Project Manager- Single Sponsor Dedicated

Job Overview

To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with sponsors Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.In addition to leading LST(s), the Clinical Project Manager may perform site monitoring as needed to support the flexible capacity model.CPM is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.

Location: Istanbul or Ankara

Essential Functions

• Leads Local Study Team consisting of CRA(s), CTA(s), for assigned study/studies

• Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with sponsors Procedural Documents, ICH-GCP and local regulations.

• Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.

• Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions

• Ensures timely preparation of country financial Study Management Agreement and maintains accurate study budget in sponsors clinical studies financial system

• Ensures timely preparation of local Master CSA (including site budget) and amendments as needed

• Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with sponsors SOPs.

• Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.

• Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.

• Proactively identifies risks and facilitates resolution of complex study problems and issues.

• Develops, maintains and reviews risk management plan on country study level: proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed.

• Plans and leads National Investigator meetings, in line with local codes, as required.

• Assists in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies.

• Ensures relevant systems required to facilitate business critical, license to operate activities (for example, Safety Reporting, Regulatory submissions, Clinical Trial Transparency) are set-up, updated and access is organised at country level.

• Plans and leads activities associated with audits and regulatory inspections in liaison with CQAD and QA.

• Ensures compliance with sponsors Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).

• Collaborates with local Medical Affairs team.

​Qualifications

• Bachelor degree in related discipline, preferably in life science, or equivalent qualification

• 5 years of prior relevant experience including > with minimum 3 years of experience in CRA role (oncology experience is mandatory)

• Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.

• Proven ability to lead and motivate cross-functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.

• Excellent project management and organisational skills

• Excellent team building, interpersonal and communication skills.

• Excellent ability to prioritize and handle multiple tasks.

• Excellent knowledge of spoken and written English.

• Good negotiation skills and ability to travel nationally