The Senior Clinical Project Manager (SCPM)  is responsible for management of all clinical operational aspects pertaining to planning, start-up and management of assigned clinical trials for the investigational drug candidates of Polpharma Biologics. The CPM provides leadership and project management to one or more clinical trials concurrently in accordance with ICH GCP as well as other international and national regulations in support of regulatory authority submissions.

Your responsibilities include, but are not limited to:

• Being a leading person with over responsibility for one or more Clinical Trials;
• Managing all operational aspects of assigned clinical trials; 
• Conducting open, effective, and proactive communication of the clinical development activities with all stakeholders (internal and external);
• Supporting the Clinical Program Head (CPH) in all aspects of the assigned clinical development program.;
• Identifying, selecting and managing external service provider and CROs;
• Organizing and facilitating study team meetings and telephone conferences with external service partners;
• Developing and reviewing study documents e.g. study protocol, informed consent form, monitoring guidelines, Case Report Forms, regulatory authority submissions;
• Overseeing and regular reporting of study progress to ensure successful completion within agreed timelines/ milestones and budget;
• Perform sponsor visits at study sites;
• Interactions with Regulatory Affairs, Drug Supply, Drug Safety and other relevant corporate functions or external development partners;
• Together with CPH, developing and controlling agreed study budget in liaison with finance department;
• Driving site selection and patient recruitment to deliver enrollment targets in time; 
• Supporting CPH of in the planning and implementation of clinical development strategy;
• Supporting the developing of Standard Operating Procedures (SOPs);
• Planning and actively contributing in GCP audits and inspections;
• Filing and maintaining study/project documents;
• Supporting the planning and execution of Investigator Meetings;
• Responsible for ensuring inspection readiness;
• Willing to travel to Polpharma Biologics Offices (within or outside Poland) as well as to business partners, service providers, and national and international (medical or industry relevant) congresses, conferences and symposia. (up to 25% of the total time).

If you have:

• Minimum of 5-8 years of clinical research and/or clinical project management, experience of conducting clinical trials, including relevant experience in managing/leading global clinical trials (in a global role);
• Bachelor’s degree in science/health-related field is preferred (Master’s or doctorate degree is an advantage);
• Experience in managing/leading the set-up of clinical trials from synopsis to “First Patient In” (incl vendor selection)
• Experience in managing clinical trial related activities (global role) between “Data Base Lock” and “Clinical Study Report” ;
• Excellent working knowledge of ICH GCP guidelines, FDA, EMA, and other relevant regulations;
• Experience operating effectively within a matrixed environment, specifically in the pharmaceutical or, biotech setting; 
• Knowledge of Sponsor Oversight and CRO/Vendor Management in Clinical Trials;
• In depth understanding of the drug development process to effectively manage internal and external cross-functional teams;
• Capability to work independently as well as a part of a broader cross functional teams; 
• Ability to work independently and make appropriate strategic decisions to operationalize and move the clinical trials forward;
• Excellent written and oral communication and presentation skills;
• Ability to prioritize tasks and resources, meet deadlines, and be flexible to changing priorities;
• Strong and influential leadership skills with proven ability to lead internal and external teams; 
• Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook, and IXRS/EDC platforms);
• Very good command of English language (ability to communicate in Polish language is an advantage).

What we offer:

• Competitive salary; 
• Private healthcare;
• Life insurance;
• Pension plan above national standards;
• Relocation package;
• Additional free day;
• and more..