Clinical Trial Manager / Clinical Researcher at Shalina Healthcare

Roles and Responsibilities

• The overall efficient day-to-day management of the trial.
• Establishment of procedures to ensure adherence to trial protocols and administrative requirements.
• Ensuring the timely recruitment of trial participants and subsequent efficient and effective data management.
• Monitoring trial progress to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify problems.
• Management of the trial budget(s) and maintenance of the accounts.
• Creating and implementing study-specific clinical monitoring tools and documents.
• Act as the point of contact for all external and internal agencies.
• Co-ordinate the preparation and publication of data, reports and information, ensuring that they meet legislative, contractual and ethical requirements.
• Understand the requirements of the various controlling bodies, agencies and frameworks, guiding the project in conforming to those requirements and co-ordinating any necessary audit processes.
• Liaison with the Trials Steering Committee and Data Monitoring and Ethics Committee with a particular view on compliance with Research Governance, Good Clinical Practice, Data Protection and Ethical Requirements.
• Work with the Chief Investigator to ensure that the trial is meeting its targets, is producing meaningful output and to predict and plan any changes that warrant requests to changes in protocol, funding or time.
• Planning and supporting the meetings and work of the various groups and bodies associated with the trial.
• Creation and maintenance of all trial files, including the trial master file, and oversight of site files.
• Assurance that personal and confidential information is restricted to those entitled to know.
• Providing Clinical Research Associate(s) with project-specific training and having regular meetings with them.
• Assuring compliance with SOPs and local regulations, and CFR, ICH, and GCP guidelines.

Requirements

• Degree or PG qualification in Pharmacy, Medical Sciences or Nursing.
• Desired: certification / diploma in clinical research.
• Work experience: 6+ years in related field (3+ years in CRM or clinical trial project lead role).