clinical-research

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.  
 
We bring together a talented team of professionals with a deep understanding of patient and physician behaviors and market dynamics. 

Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. 
 
Syneos Health supports a diverse, equitable and inclusive culture that cares for colleagues, customers, patients, communities and the environment.

Syneos Health

• Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity
• Oversees site interactions post activation through site closeout
• This may include patient recruitment, investigator payments or other related activities
• May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT)
• Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/CeMs) is aware of the contractual obligations and parameters
• Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables
• Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope
• Employs strategic thinking and problem-solving skills to propose and implement risk mitigations
• Participates and presents in key meetings such as Kick Off Meeting
• Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members
• This may include accompanying CRA team members to sites for observation or conflict resolution
• Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines
• Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities
• Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan
• Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed
• Ensures access and audit trail reviews are conducted as required
• Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study
• Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality
• Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools
• Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan
• Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan
• Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans
• Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity
• Document requested revisions and approvals in CTMS
• Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines
• Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables
• Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements
• Provides solutions for obstacles in protocol execution and site management
• Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations
• Supports Inspection Readiness for clinical trial management scope
• Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks
• Develop and support execution of corrective action plans at site and study level
• Supports and completes activities to achieve data cut and lock deadlines
• Provides feedback to line managers on staff performance including strengths as well as areas for development
• May be assigned to larger, more complex trials or may coordinate clinical activities for a team of CTMs across a portfolio of projects
• May coach and mentor CTMs regarding functional clinical delivery, evaluation of project risks, and action implementation

Senior Clinical Trial Manager – Poland, hybrid model

Sr Clinical Trial Manager managing clinical trial oversight and ensuring compliance in Poland. Collaborating across teams to meet project milestones and patient safety standards with a hybrid work model.

Medtronic is a global leader in healthcare technology solutions, working to address the most complex and challenging medical conditions. With over 95,000 employees in more than 150 countries, the company is focused on accelerating access to healthcare technologies and advancing inclusion, diversity, and equity in healthcare. Medtronic collaborates closely with healthcare professionals to innovate and optimize treatments and therapies, thus inspiring hope and new possibilities for patients worldwide. The company's commitment to healthcare extends to its focus on impactful solutions and sustainable practices.

A global healthcare technology leader — boldly attacking the most challenging health problems facing humanity with innovations that transform lives.

Medtronic

• Provides Clinical/Medical Leadership at Business Reviews and discussions with the respective Country Leaders in the ACEE region.
• Contributes to the development of a Clinical & Medical affairs strategy and execute them in their sub-region.
• Seen as the Voice of the Patient and the HCP.
• Provides Strategic Leadership for the development of Clinical strategy across OUs relevant to the region in Medtronic sponsored studies, Collaborative Research and ERPs including execution of Clinical Research and Medical Affairs.
• Ensures that the studies are scientifically valid and meet all relevant regulatory requirements and be conducted within ethical guidelines.
• Leads execution for both local and global studies, manages clinical research projects across Medtronic therapies across multiple businesses.
• Ensures that all clinical studies are published based on a fair assessment of the safety and efficacy of the tested products and attainment of product approvals in a timely matter.
• Partners with the OUs/Marketing regionally to seek insights and disseminate the published data both globally and regionally.
• Partners with Regulatory to contribute and partnering to implement regulatory strategies to obtain timely product approvals from worldwide regulatory bodies.
• Develops and maintains a deep knowledge and understanding of the science behind our products and is seen as an internal expert.
• Responsible for the governance and compliance within the region.

Clinical Research and Medical Science Director

Clinical Research & Medical Sciences Director at Medtronic overseeing clinical research in Africa & Central/Eastern Europe. Leading innovative medical technology strategies and ensuring regulatory compliance.

Medtronic is a global leader in medical technology and services, driven by a mission to alleviate pain, restore health, and extend life for millions of people worldwide. The company develops groundbreaking healthcare solutions and partners with healthcare professionals to optimize treatments for complex conditions, offering a wide range of products, therapies, and integrated health solutions. With a presence in over 150 countries and a commitment to health equity and sustainability, Medtronic aims to improve healthcare access and outcomes globally.

• Provide Clinical/Medical Leadership at Business Reviews
• Contributes to the development of a Clinical & Medical affairs strategy and execute in sub-region
• Partners with Regulatory for regulatory strategies
• Develops and maintains knowledge of the science behind products and acts as a Speaker in scientific meetings

Clinical Research & Medical Sciences Director managing healthcare access and innovation in the ACEE region. Responsible for strategic leadership in clinical research and medical affairs.

Hybrid Clinical Researchers roles in Poland

Browse 3 hybrid clinical researchers roles hiring in Poland plus related opportunities such as medical writer, biostatistician, data scientist, clinical operations, medical director and medical reviewer.

3 jobs found

Senior Clinical Trial Manager – Poland, hybrid model

Syneos Health

Clinical Research and Medical Science Director

Medtronic

Clinical Research and Medical Science Director

Medtronic