職位描述
? Lead one or more multi-functional Clinical Study Team(s) or oversee the activities of the operational Clinical Study Team(s) at Partner. In Partnered trials, leading the Joint Clinical Study Team composed of UCB and Partner team members.
? Work closely with the CPD and other team members as required and serving as the key contact for the assigned studies.
? Operationally coordinate and manage or provide oversight of the Partner for clinical studies including but not limited to:
? contingency planning,
? tracking and management timelines
? ensuring Clinical Trial Management System (CTMS) reflects the current trial status
? ensuring the TMF reflects current trial status
? providing clear, accurate and timely information flow and status updates internally and externally as required
? selecting and managing vendors as applicable
? Regularly review CRO/Partner performance, as applicable, through regular meetings, review of status reports, KPIs, metrics and other deliverables. Findings to be communicated internally within UCB as appropriate and all issues to be followed-up in a timely manner. Closely cooperate with O & C and if applicable relevant committees/governance bodies and/or CQA regarding the performance and quality of work received by vendors.
? Track and manage budgets (e.g. forecasting)
? Represent (Joint) Clinical Study Team(s) as active member of Clinical Subteam.
? Ensure adequate participation, contribution and accountability of the study team members or the oversight of these duties performed by the Partner Project Manager.
? Ensure quality and adherence to the relevant SOPs, GCP, regulatory guidelines and working practices.
? Ensure that the study is audit/inspection ready at all times and any result findings from audits/inspections are addressed appropriately and in a timely manner or the oversight of these duties performed by the Partner Project Manager.
? Provide input to the development of Study Concepts and drive the creation of Protocol Summaries (including particular emphasis on operational expertise) and consolidate contributions of all team members (may include Partner experts).
? Collaborate with members of Clinical Study Team(s), Clinical Subteam or Partner to develop clinical trial protocols and protocol amendments.
? Collaborate with members of Clinical Study Team(s) to develop study documents (e.g. Informed Consent Form/Patient Information, CRF, Monitoring Guidelines, data cleaning plans, statistical analysis plans, vendor contracts) either directly or in case of partnered trials by providing input and/or approval as applicable.
? Ensure that Clinical Study Reports (CSRs) meet the objectives of the trial and correctly reflect the data, in collaboration with the UCB and/or Partner Clinical Study Team Members and the Clinical Subteams.
? Provide study specific training for internal (i.e. UCB) and external (e.g. vendors, investigators) team members. For partnered trials this will preferably occur in a train the trainer mode.
? Ensure Partner is informed appropriately about any relevant Sponsor information that affects the management of the partnered trial.
? Ensure appropriate response to new safety information (e.g. update of trial documents) and ensure safety report distribution. For partnered trials oversee these duties performed by the Partner Project Manager.
? Participate in clinical summary document generation (e.g. INDs, NDAs) and other submission activities for study specific issues, results or analysis and description of individual cases.
? Contribute to process improvement initiatives and share best practice experiences with line managers and peers.
? Cooperate with and provide feedback to the UCB members of the partnering governance bodies as appropriate.
? Travel including overnight stays, required.
? May be asked to
? mentor colleagues
? present the clinical trial internally or to an external audience
? contribute to publications as appropriate
? Perform other tasks as deemed necessary by the Company, e.g. duties described in the ACPM job description.
JOB PROFILE：
Experience (List the type and length of experience)
? At least three years’ relevant experience in clinical development including team leadership
? Experience or capability to manage outsourced regional and/or local clinical studies from study start-up to study report completion
Specific skills (Include specific skills and knowledge necessary to meet the objectives of the position)
? Clinical trial management and team leadership
? Motivation, mentoring and integration of individuals on multi-functional international teams
? Delivery of scientific/medical presentations and training to both large and small audiences
? Excellent verbal and written communication in English
? Proficiency in the Microsoft office suite
? Good interpersonal skills
? Excellent time management and organizational skills
? Negotiation skills
? Scientific and technical knowledge:
- GCP and regulatory environment
- Medical knowledge and research expertise
- Basic principles of data management and statistics
