Clintec is actively recruiting a Project Manager to join our expanding global company in Poland. This role is office based in Warsaw. By working for Clintec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits.
The Project Manager / Study Leader is responsible for leading a cross-functional study team (core and extended) and for providing the team with direction and guidance to enable successful study delivery. The PM/SL is the main liaison between the study team and the Clinical Program Team (CPT) starting with study handover through to close-out and archiving. The PM/SL is accountable to the CPT for the delivery of a study according to agreed upon timelines, budget and quality standards by ensuring an effective partnership and teamwork within study team and/or external partners.
The Project Manager / Study Leader leads the study team and/or study oversight team in accordance with the Study Team Operating Model (STOM), Project Management Framework and/or clinical outsourcing model (SCOUT), current clinical trial regulations (e.g. ICH GCP), Standard Operating Procedures (SOPs), policies and best practices (e.g. guidelines) and in line with company values and behaviours.
Responsibilities of the Project Manager:
Lead and coordinate a cross-functional study team of experts in accordance with STOM and its roles, accountabilities and responsibilities framework (RACI) to ensure the clinical study progress as planned driving achievement of milestones according to timelines, budget and quality standards
Lead and facilitate communication across all functions and provide guidance and support to the core and extended study team members as needed and in accordance with study-specific communication plan
For outsourced studies, be the primary point of contact for the CRO Project Manager to ensure study delivery according to agreed upon timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with relevant SOPs and guidelines (e.g. description of services and transfer of obligations)
Provide input into and hold accountability for the development of essential study level documents (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)) in accordance with relevant SOPs
Ensure all external service providers (i.e. central laboratories, IXRS, ePRO, etc.) engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented
Develop and maintain relevant study plans (e.g. global study management plan and its relevant components such as study project plan SPP) including required input into study level quality and risk management planning (e.g. risk-based quality management, proactive risk and contingency plans, etc.) ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team
Oversee study level performance against agreed upon plans, milestones and key performance indicators (KPIs, quality and operational) by using company tracking systems and project timelines (e.g. SPP, data flow metrics dashboard, CTMS or eTMF dashboard) and communicate any risks to timelines and/or quality to CPT, along with proposed mitigations
Identify and report quality issues that have occurred within the study in accordance with relevant SOP and collaborate with all functions as necessary to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders (e.g. CPT, quality assurance staff, functional line management, etc.)
Oversee Trial Master File (TMF) completion in accordance with relevant SOPs, including ensuring the TMF plan and Expected Document List (EDL) are in place and that QC activities are performed on an ongoing basis to ensure TMF completeness at all times
Ensure timely compliance with company-wide governance controls (e.g. Delegation of Authority, Sunshine Act, ACCORD attestations, Clinical Trial Transparency)
The PM/SL is responsible for study budget re-forecasting following initial budget estimate provided by the CPT and accountable for study budget management through the study lifecycle and for providing budget progress reports to the CPT including any financial risks and mitigation plans (as part of the ongoing study change control process)
Ensure studies are inspection-ready at all times, according to ICH-GCP and SOP and relevant policies/guidelines; PM/SL is the primary Study Management & Operations (SMO) point-of-contact in the event of an audit or inspection
Provide regular feedback on individual performance to the study team members and their line managers to support their professional development; may mentor less experienced colleagues
Work on non-drug project work such as SMO representative in process improvements and/or leading improvement projects as discussed and agreed upon with their manager
University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research
7 years of relevant clinical experience in the pharmaceutical industry, including project management experience, or equivalent combination of education, training and experience
Vendor management on at least on regional experience is a must
Extensive knowledge of clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development
Demonstrated solid project management skills and knowledge of relevant tools
Strong, demonstrated abilities/skills in team leadership
Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders, along with strong conflict management skills
Excellent communication and interpersonal skills
Strong strategic and critical thinking abilities
Strong organizational and problem-solving skills
Ability to manage competing priorities
Advanced degree, Masters level education (or higher)
Proven project management experience on at least regional level
Experience in all phases of a clinical study lifecycle
Proficiency in Microsoft Project
Clintec is a dynamic, UK headquartered, privately owned, full service Contract Research Organisation with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. At Clintec we have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.
Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a competitive salary and rewards package.