CML

Job description

The CML is responsible for the planning, conduct, completion and reporting of clinical trials under supporting and supervision on a local OPU level according to all applicable regulations and general quality requirements.

Job Profile

1. Resource management • To be involved in evaluation of CRA resource for assigned trial, • Prepare investigator and site profile and decide on site selection by supervision, • Responsible for IMP import, distribution, return and destruction per local regulation and BI requirement under oversight, • Ensure all required local study documents including the patient information and informed consent documents in local language as well as local protocol amendments and all documents in the ISF, in close cooperation and with input from the TCM, CRA team and all other involved functions, • Responsible for translation and reviews of trial medication labels in cooperation with local DRA or other internal review functions, • In charge of clinical trial related equipment imported or purchased in China OPU, and relevant distribution, return, • Work with CRO manager/Purchasing on CRO/Vendor selection and provide feedback on service received. 2. Trial oversight, management and operational activities • Ensure timely study milestone delivery, • Responsible for preparation of the enrolment plan with support if needed, • Responsible for routine tracking of the enrolment plan vs actual enrolment, • Ensure timely cleaning and delivery of trial data and documents, supports the completion of the Clinical Trial Report (provision of appendices) with support if needed, • Update systems timely and ensure the completeness and accuracy, e.g. CTMS, • Ensure patient safety during the conduct of the trial by reviewing regional/local safety information. 3. Budget management • Understand BI Cost structures, especially the trail budget; Clearly distinguish the cost allocation between BI & Vendors, • Establish and monitor local budget aspects including investigator fee with support if needed, • Prepare budget specification and offer for assigned study, • Responsible for IMC review through closing working with medical controller; Familiar with Finance budgeting cycle and take actions according to the timeline, • Periodically tracking and control the actual spending and extra budget based on the most updated milestone; Ensure study budget is well tracked and controlled within defined deviation percentage. • Understand updated Finance SOPs and the impacts on daily business. 4. Quality management • Meet mandatory compliance requirements and standards including ICH-GCP, BI SOP/guideline and regulatory requirement, • Coordinate to ensure appropriate study specific and medical/scientific training and advice delivered to local team including CRAs, CRO and site staff, • Act as CAPA leader for Trial case, • Ensure appropriate escalation of issues related to trial conduct and procedures as well as adequate support of CAPA, • Develop Risk Management Plan under guidance from line manager & timely maintenance during the whole trial process, • Conduct co-monitoring per BI SOP/Guideline request, • Closely monitoring the clinical data including patient safety data to be reported timely, correctly. 5. Provide leadership • Provide leadership in the oversight and management of investigational sites in partnership with other key stakeholders (e.g. CRAs), including correct handling of IMP, patient data and material (e.g., biological samples) with support if needed, • Lead local team including CRO for outsourced study or CRA/CTA to manage the trial in accordance to protocol, SOP, ICH-GCP and regulatory requirement through routine meeting and timely communication including e-mail, phone call and newsletters by supervision, • Close contact with the global trial team and support of global trial activities, • To participate in communication with cross function including DRA team, CDMA team, PV team and BDM team, etc.

Requirements

• Bachelor or above in medical, nursing, pharmaceutical or other bio-science related area. • Structured mind-set, good scientific, medical and analytical thinking, • Basic medical knowledge of the disease under investigation, trial related risks, and understanding of the Investigational Medicinal Product, procedures and study design and their potential impact on patient's wellbeing, • Good knowledge of the Clinical Development process, including the regulatory requirements is preferred, • Proficiency in all common office software and smooth self-training of new software programmes (user), • Ability and willingness to travel domestic and overseas and to use electronic means of communication.