Clinical Trail Manager
1 month ago
Clinical Trial Manager
Duties: As Clinical Trial Manager (CTM), accountable for the operational management of the local component of a clinical trial. Level of oversight assures achievement of trial recruitment commitment, timelines, budget and internal/external quality standards.
Leads local trial team to ensure integrity of trial conduct, assurance of patient safety, and that local/regional component of trial is planned, conducted and reported in line with regulatory requirements. Requires orchestration of local trial team, and integration with other functions as necessary throughout planning, conduct and closeout of trial.
Works within a complex GCP and regulatory environment and on global clinical trials with multidisciplinary, international teams and with various internal and external stakeholders including suppliers and investigational sites. Represents the company for the function at internal and external meetings, e.g. with investigational sites or regulatory agencies/inspectors. Failure can have impact on project deliverables (e.g. timelines, costs, integrity of trial data), the reputation of client with stakeholders and regulatory agencies. More than one assignment in parallel requires balancing conflicting priorities. Is involved in design and implementation of new innovative method as working group member.
Education:
Bachelor's degree plus a minimum of 6 years of experience in clinical research, preferably in the pharmaceutical industry; or Master's degree or PharmD plus a minimum of 4 years of experience in clinical research, preferably in the pharmaceutical industry; or PhD or MD plus a minimum of 2 years of experience in clinical research, preferably in the pharmaceutical industry.
Skills and Experience:
Required Skills:
CLINICAL TRIAL MONITORING
CLINICAL TRIAL
CLINICAL OPERATIONS
GCP
Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.Company DescriptionMaxis Clinical Sciences provides complete Solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and an integrated research competence center. The company provides 24×7 delivery globally, with teams across the world’s 3 largest continents – North America, Europe and Asia. We operates with a problem-solving approach that believes in promoting genuine relationships & steady communication. It works as true clinical and digital competence center and provides services with 200 plus techno-functional, domain experts, each with 12+ years of average experience.\r
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Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.
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