Clinical Trial Manager (PM role), insourced to European Pharma
Location: Shanghai Jing'an Temple /Beijing Liangmaqiao office based
Therapeutic area: global phase II-III studies in Cardiovascular, Renal, Metabolic 心肾代谢领域
1年以上项目管理经验，外资药厂/CRO工作背景者优先
有心肾代谢治疗领域项目经验者优先
英语听说读写流利，有留学背景优先
出色的沟通能力和问题解决能力
Basic purpose of the job*
Accountable for the operational management of the regional/local component of a clinical trial. Level of oversight assures achievement of trial recruitment commitment, timelines, budget and internal/external quality standards.
Leads the local/regional trial team in the capacity of R/OPU Clinical Trial Manager (CTM)
Trial Preparation, Conduct and Closeout:
1. Selected sites conduct and deliver the trial according to the clinical trial protocol, within trial timelines, and in compliance with ICH-GCP and all other relevant external regulations.
2. Lead and support local trial team and investigative sites in timely preparation of required trial documents, contracts and necessary approvals.
3. All Regulatory Requirements are satisfied prior to trial/site initiation.
4. Where necessary, set up and manage external suppliers that meet requirements of local/regional trial operations.
5. Set up, manage and review R/OPU trial budget to ensure appropriate level of financial oversight. Timely budget updates based on trial changes.
6. Ensure appropriate trial-specific training of R/OPU internal and external partners in line with Trial Training Plan
7. In collaboration with Site Monitoring Lead and CRAs, ensure
provision of appropriate trial oversight for the trials by monitoring compliance of trial sites and BI team to GCP, local regulations, BI SOPs (for BI staff and issue), and adherence to trial protocol.
adequate trial supply distribution to sites. continuous and timely data entry and cleaning, and on time Data Base Lock.
8.Trial contact for CRAs, investigators and site staff.
9.In collaboration with Trial Resource Specialist and with supports from CRAs as appropriate, ensures collection of required documents, with timely, complete and compliant archiving of all relevant documents for the eTMF and CTR Appendices.
Management and Relationship Responsibilities
Develop and maintain company relationships with external experts and investigational sites by coordinating and ensuring cross-functional collaboration amongst Clinical Operations and Medical Affairs on Regional/ local level, and supporting CRAs in site contacts.
Collaborates with other BI functions to support Trial Management topics and support integration across Medicine.
Participate in working groups related to Trial Management, represent trial on local and regional level, providing updates on trial within R/OPU.
Regulatory and / or Organisational Requirements*
Ensures all tasks are carried out in accordance with respective applicable BI SOPs, BI Business Practices and regulatory requirements. Ensures that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with BI Values
Leads local trial team to ensure integrity of trial conduct, assurance of patient safety, and that local/regional component of trial is planned, conducted and reported in line with regulatory requirements. Requires orchestration of local trial team, and integration with other functions as necessary throughout planning, conduct and closeout of trial.
Works within a complex GCP and regulatory environment and on global clinical trials with multidisciplinary, international teams and with various internal and external stakeholders including suppliers and investigational sites. Represents the company for the function at internal and external meetings, e.g. with investigational sites or regulatory agencies/inspectors. Failure can have impact on project deliverables (e.g. timelines, costs, integrity of trial data), the reputation of BI with stakeholders and regulatory agencies. More than one assignment in parallel requires balancing conflicting priorities. Is involved in design and implementation of new innovative method as working group member.
Interfaces*
Functional leadership role within a clinical trial and within responsible country/ region with no direct reports.
Lead and/or project manage local/regional trial team members and colleagues including but not limited to: CRAs, Project Assistants, Local TMF Records Specialists, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Quality Medicine, local/internal Patient Advocacy Team.
Liases and partners with global trial team members including but not limited to: CT Leader, Site Monitoring Lead, Medical Monitor, Trial Data Managers, Pharmacovigilance, Clinical Trials Supplies Unit, Strategic Sourcing, TMM.
Provides oversight and relationship management with external partners including but not limited to: Investigators, Study Coordinators, Central Ethics Committees, Hospital Pharmacists, Research Networks, Local Suppliers
Job Expertise*
Solid communication, project management, networking/stakeholder management and team leadership capability. Understanding of the scientific and/or technical components of the clinical development process, and associated regulatory requirements
Job Impact*
- BI sponsored trials conducted according to applicable regulations and BI SOPs/ procedures to safeguard patient safety/ wellbeing, and data integrity;
- delivery of trial commitments, including quality, timeline and budget;
- each CT Manager's oversight allows for delivery of successful trial data towards provision of safe and efficacious medications
Minimum Education/Degree Requirements*
University degree in life sciences or related field, higher degree/qualification preferred (e.g. MSc, PhD).
Required Capabilities (Skills, Experience, Competencies)*
5+ years of relevant experience in the clinical research field with 1-2 years of experience in clinical project management in global company preferred.
Adapts communication style to audience to effectively influence stakeholders.
Demonstrates active listening skills and cultural awareness.
Scientific and Operational Expertise: Demonstrates scientific knowledge and operational expertise across all aspects of clinical trial execution ie start-up, conduct and reporting. Dimensions of trial complexity include protocol phase and indication, # patients, # sites, # countries, # vendors.
Leadership and Influence: Inspires team to achieve a common goal. Translate complex situations to actionable parts. Anticipate and resolve challenges through effective influencing of cross functional team members and management
Strategic Mindset: Anticipates future trends and needs and translate them into strategies that fits the overall TA portfolio and the ambition and values of BI Contributes to cross functional initiatives within and beyond medicine.
Project Management: Plans, sets priorities, defines actions, makes effective use of resources, proactively strives for clarity to accomplish the business deliverables