The Role for Associate Clinical Site Manager (ACSM) has been created in PAREXEL to train and develop people, without any experience in clinical research. During the training period (minimum 6 months), ACSM is responsible for learning and developing skills and competencies to work in a clinical research environment. At the end of this period the ACSM would be ready to work independently within Global Clinical Operations Department in PAREXEL.
Key Accountabilities:
• Complete all mandatory trainings in LMS
• Do all pre-work that applies to each training activity
• Complete and deliver on time all activities including post-training activities
• Attend all on-going, relevant trainings, including Continuing Education Workshops (CEW) that are applicable
• Attend all training activities organized for this role (in the country orat international level)
• Learn to work in compliance with ICH-GCP Guidelines, applicable international and local regulations, PAREXEL SOPs, other PAREXEL and study specific procedures and requirements
• Arrange on-site observational visits and logistics (e.g. travel arrangements).
• Perform on-site observational visits (Qualification, Initiation, Monitoring and Termination) with appropriate support; apply judgment and knowledge to independently resolve site issues,
Work with the mentor in the visit report and follow up letters writing activities.
• Successfully pass all assessments related to this role
• Complete routine departmental administrative tasks in a timely manner (e.g. times, metrics, concur etc.)
• Attend to all internal activities and corporate meetings.
• Perform project specific training agreed to understand the main project activities
• Ensure the basic understanding of project scope, milestones, budgets, and time codes and strive for high quality, timely, and induction period, shadow efficient delivery working in two or three.
• Help the local team in completing Clinical Trial Management defined trial
Systems (CTMS) and study specific trackers
• Track, scan, code and apply naming convention and send documents to the relevant study e-CF Work In Progress (WIP) area and Central File (CF) area of PMED as per the Central File Maintenance Plan, if applicable
• Filling and Archiving paper wet-ink documents in the Central Files office location as per the Central File Maintenance Plan (CFMP) if applicable
• Assist with the creation and completion of the Investigator Site File if applicable
• Support in on-site / remote visits preparation and follow-up if applicable
QualificationsSkills:
• Ability to interact professionally within a client organization with the support of manager or team members
• Flexible and positive attitude with respect to work assignments and new learning Ability to manage multiple and varied tasks with enthusiasm
• Attention to detail
• Willingness to work in a matrix environment and to value the importance of teamwork
• Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word
• Sound interpersonal, verbal, and written communication skills
• Sound proactive and problem-solving skills
• Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables
• Effective time management to meet daily metrics, team objectives, and department goals
• Shows commitment to and performs consistently high-quality work
• Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned
• Willing and able to travel locally and internationally occasionally as required.
• Holds a driver’s license where required.
Knowledge and Experience:
• Previous relevant work experience valuable
• Proficient in written and oral English and fluent in relevant local language
Education:
• Educated to degree level (biological science, pharmacy or other health-related discipline preferred) or equivalent nursing qualification
Please note – in order to be considered, you must be able to speak English, French and Dutch fluently. This is a full-time office-based program both focused on CSM and ICSM for a 5 month duration.
2020-07-17 01:00:53
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