蚌埠招聘

Key areas of responsibility:
• To ensure effective communication of all responsible trial/project related issues between HQ and BAC and take on the responsibility of leading an local, regional or international project team to achieve team deliverables within agreed timelines and in accordance with scientific, quality and/ or regulatory requirements
• Responsible for representing BAC in global clinical development teams or other global teams
• To ensure BAC delivers to the company’s clinical and business development strategies according to project plans and business priorities.
• Clinical trial management
• Team Coordination
• Training

Main job tasks:
Under the general supervision of the Clinical Research Director (CRD), the Clinical Research Manager (CTM) contributes his/her knowledge of local health care systems, disease management and clinical research capacity into clinical research strategy development and is responsible for clinical research conduct in BAC.

Strategic Activities:
• With the Clinical Research Director (CRD), CTM contributes to the development of a local research strategy for country. Perform tactical assessment of country capability, disease prevalence, treatment guidelines, competitive landscape, business interest; medical availability etc to aid appropriate placing of studies. Provide input into appropriate prioritization of Novo Nordisk studies, consistent with local and regional strategy, balancing the short term and long term needs of local subsidiary with those of the division.
• Ensures active management of site Relationships site relationships. With CRD, CTM develops and executes a plan for the identification and development of clinical research preferred partners (high performing sites, centre of research excellences etc.) to ensure availability of adequate high quality investigator sites to meet clinical research needs. Acts as conduit to the rest of the organization for contacts with investigators and scientists to help relationships between company and opinion leaders.
• Works externally to represent Novo Nordisk and clinical research on committees, as needed.
• Internally, participate on committees, working teams etc to represent the operational aspects of clinical research.
• Responsible for compliance with corporate policies, procedures and quality standard

Clinical Trial Management:
• Manage the performance of a team of CRAs within China to support business needs, including but not limited to work allocation, staff development and performance appraisal. Provides input for capacity planning, including reporting of current manpower and forecasting of CRA capacity and needs, to provide efficient use of resource for country. Executes research strategy within China including managing local research initiatives and meetings to meet the company needs for clinical research data for product registration and market support data.
• Management of clinical research in China according to ICH-GCP, Novo Nordisk global standards and local law and regulations (drug law, customs and IRB/ERC process), to provide an efficient clinical research capacity for the company’s needs for registration and marketing support data.
• Review and discuss scientific issues and protocol details with IRB/ERC and regulatory agencies, if required.
• Work with CRA/SCRA and other subsidiary support functions (CQTS, CTA) to ensure consistency of processes and protocol implementation in different investigative sites, to reduce variability and provide predictability.
• Interacts with sites as needed to resolve site operational issues to meet commitments in a timely manner
• Attend local Investigator Meetings as necessary.

People and Resource Management:
• Manage SCRA/CRAs – career development, performance reviews, etc. Support escalation of issues from CRAs.
• Manage local Novo Nordisk clinical research resources (manpower & budgets). Liaise with local HR (P&O) and finance functions as required. Be aware of current and forecast manpower capacity in his/her territories.
• Primary local point of contact providing input for outsourcing research capabilities.
• Provides training, support and mentoring to the CRA to ensure the continuous development.
• Ensures CRA compliance to corporate policies, procedures and quality standards.

Other individual assignments:
E.g. represent Novo Nordisk in external working groups and at conferences as well as internal focus groups.

Qualifications (minimum requirements):
• High degree of trust-confidence
• Strong leadership and excellent team player
• Strong stewardship skills, excellent interpersonal skills and negotiation skills
• Excellent communication skills (written and verbal) in local language and English
• Excellent understanding of the drug development process, local and regional regulatory processes, relevant diseases and therapies, and the medical practice in a region or country
• Excellent understanding of the ICH/GCP and local regulators specially regarding contracting and payment
• Excellent Project Management skills

Education:
 Bachelor’s degree or above of Medical Science

Professional experience:
 Previous management experience is required. Mentoring experience is required
 At least 5 years of clinical research experience, including people management. Equivalent external experience will be considered
 Knowledge of Good Clinical Practice (GCPs), ICH Guidelines, and local regulations, research process and scientific knowledge as relates to clinical trial conduct.
 Willingness to travel

Additional description
Specific personal and job related demands
Task dependent:
Aim at keeping timelines, quality goals, professional standards, financial and time budgets according to e.g. project plans, contracts and other agreements established for the individual tasks. Report progress including deviations appropriately.
Personal:
Aim at keeping personal 3P goals and report progress including deviations appropriately. Keep holiday and sickness registration updated. Consider personal on-the-job training. Propose further personal training and educational programmes. Keep personal CV and training log updated. Plan for personal career development. Train and assist beginners and newcomers on the job.

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