CLINICAL TRIAL LEAD

Great job opportunity for a CLINICAL TRIAL LEAD for one of the most reputable, full-service providers of CRO and SMO.

Established in, with locations in Central & Eastern Europe and 290 full-time dedicated professionals, COMAC MEDICAL is a recognized leader in clinical research and provides innovative and non-conventional solutions of high quality for pharmaceutical industry.

Currently we are looking for a professional inspired by the opportunity to manage and oversee clinical trial projects, ensure quality, collaborate actively with the clinical project managers and sponsors, lead the clinical monitoring team.

CLINICAL TRIAL LEAD

What is expected to be done?

Project Related responsibilities:

• Monitor activities oversight of assigned projects and as primary liaison for all clinical monitoring issues;
• Collaborate with Clinical Monitor Manager to ensure adequate CRA/RA resources are assigned to the project;
• Lead and coordinate the CRA team, ensure appropriate CRA visit scheduling per protocol and monitoring;
• Provide oversight of the entire site supervision process for the life cycle of the trial sites;
• Collaborate with the CRA to develop Corrective Action Plan (CAP) relateed to non-compliance at site if necessary.
• Assist in GCP audit preparation and file reviews for different sites, internal teams and Clinical Research Associates;
• Assist PM for identification of potential risks to site performance and monitoring activities;
• Attend the project kick-off meeting, launch investigators meetings and make presentations;
• Conduct and assist with project specific training, oversight and mentoring of CRAs and RAs
• Communicate with Data Manager, Pharmacovigilance Manager and Medical Monitor on resolving project-related issues and obtaining follow-up information;
• Review ERP System information to provide oversight and ensure timely entry of all operational information;
• Provide regular status reports to the PM, Management and the Sponsor on site initiation, enrolment oversight, monitoring visits and trip report completion;
• Provide input into and/or develop study related materials such as Clinical Monitoring Plans, Data Management Plans, eCRF forms and completion guidelines;
• Ensure that compliance with the applicable SOPs, quality documents and guidelines, protocol and amendments is maintained by the CRAs/RAs during the project.

Human resource related Responsibilities:

• Contribute to CRA team knowledge by acting as Subject Matter Expert
• Conduct field training and assessment of CRAs
• Provide co-monitoring with assigned CRAs
• Assist in completion of monthly KPI

What is required for the role?

• Graduate or postgraduate degree;
• At least 6 years as a Clinical Research Associate/Clinical Monitor;
• At least 1 years’ experience providing work direction and leadership to people and teams including employees’ development, performance management and conflict resolution
• Thorough knowledge of clinical research process, including working knowledge of all functional areas of clinical trial management.
• Working knowledge of current ICH/GCP guidelines and applicable country-specific regulations.
• Excellent organizational, communication (verbal and written) and interpersonal skills.
• Ability to reason independently for the purpose of assessing and recommending specific solutions in clinical settings.
• Positive attitude and ability to interact with all levels of staff.
• Ability to work under pressure and to keep tight deadlines.
• Proficiency in English.
• Working knowledge of Word, Excel, and Power Point.

Why to join Comac Medical?

• Great team of knowledgeable, high-achieving and experienced professionals;
• International and diverse work atmosphere;
• Challenging projects in a different therapeutical area as well as in early phases;
• Opportunity to enrich professional skills and progress in career development;
• Competitive remuneration;
• Professional trainings;

Core strengths of Comac Medical

• Proven track record for quality and delivery;
• Established and trusted relationships with KOLs;
• Motivated, capable and dedicated team;
• Global full-service capabilities;

If you are interested, challenged and convinced that the job opportunity is exactly for you, do not hesitate and send your detailed resume in English.

Only the shortlisted candidates will be contacted in a timely manner.