佛山招聘

Position statement：

Clinical Operation Management:

1、Manages and supervise all employees within global clinical operation dept for their performance in alignment with functional growth strategy and company goals

2、Oversee the global clinical operation teams, internal and external (CRO), to ensure GCP compliance and adherence to Quality systems.

3、Responsible for the execution of clinical study plans to meet the timeline in accordance with the goals and objectives of the company

4、Work with the study team to support development of study protocol, case report forms, PMP, MM, SMP, MDRP, and procedures required in all aspects of conducting clinical trials.

5、Collaborate with finance dept to plan and manage clinical trial budget in accordance with the goals and objectives of the company.

6、Oversee the negotiation and administration of contracts, investigators and other organizations involved in clinical studies.

7、Oversee the management of external vendor relationships to facilitate effective communication and efficient interactions with them to optimize clinical trial performance

8、Support interaction of with Key Opinion Leaders and Scientific Advisors to develop the clinical development program strategy and implement a clinical trial plan in alignment of program strategy

9、Supports company business development efforts when needed.

Project Management:

1、Regularly track and communicate study/project status to relevant team members, functional areas and executive management, including site and subject level metrics, challenges and opportunities; prepare monthly/quarterly progress reports.

2、Negotiate agreements/budgets with clinical sites, consultants, and vendors in collaboration with legal and compliance departments as they relate to clinical studies and projects.

3、Manage and set annual goals, objectives and development plans for clinical research. Lead and/or participate on internal cross-functional team meetings.

Clinical Quality Assurance (in conjunction with CQA) Responsibilities:

1、Work closely with QA consultant to assist co-author, review and revise Clinical department Standard Operating Procedures( SOPs ).

2、Assist Global head of Clinical Operations to ensure/coordinate appropriate and complete resolution of findings/non-compliant issues, quality investigations, etc. in a timely manner, including approval of corrective action and preventative action (CAPA) plans, as necessary.

3、Assist to conduct in internal audits if needed. Identify the need for, conduct and/or assist in external audits (includes, but is not limited to, investigator sites, central IRBs, CROs and clinical labs).

4、 Interact with auditors in the scheduling process, kick-off meetings with auditors and internal groups, assist in the drafting of audit plans, confirmation letters and agendas, etc.

5、Assist to oversee the audit response process for the Investigator Site and Contract Research Organization (CRO) audits/inspections and ensure acceptability of actions to address findings through the CAPA process.

6、Identify potential systemic gaps and coordinate with the appropriate stakeholder to ensure timely remediation.

7、As appropriate, escalate issues of critical non-compliance and/or lack of urgency in remediation to clinical department senior management.

8、Assist QA to perform program specific root cause analysis of compliance issues and provide the appropriate metrics for tracking and trending for the overall QA reporting requirements to functional and senior management.

9、Assist with inspection readiness, and regulatory inspections as needed.

Position statement：

1.BS/BA or higher of Science degree in a life sciences discipline, advanced degree preferred.

2.At least 10 years of biopharmaceutical industry with relevant experience in managing clinical trials in either sponsor or CRO organizations, with a strong track record of successful trial initiation and execution.

3.Prior experience in the oversight of the operational aspects of all stages of clinical studies, preferably in a global environment.

4.Thorough knowledge of GCP, CFR, ICH guidelines and other US and international clinical regulatory.

5.A detailed understanding of overall strategic direction, interrelationships and business needs.

6.Exhibits the ability to recognize the need to seek assistance from or inform Senior Management of specific risks/issues; understands when decision making can occur at the study team level versus when there is a need for escalation to the program level or to Senior Management.

7.Strong interpersonal communication (written and verbal), organizational and prioritization skills.

8.Excellent leadership and interpersonal skills with an ability to effectively work and problem solve within a multidisciplinary team and to effectively manage external vendors/CROs.

Demonstrated adaptability, flexibility, independence and resourcefulness to thrive in a mid-sized company environment.

深圳市原力生命科学有限公司于2016年11月4日在深圳市坪山区注册成立，注册资本383.5887万人民币，办公用房占地1411.06平方米。深圳原力生命科学有限公司是一个着重于临床前及临床阶段的新药研发，以肿瘤免疫和靶向治疗为重点，为肿瘤患者开发能够挽救生命的创新抗肿瘤药物研发公司。深圳原力生命科学有限公司引进一组由全职回国的美国院士孙勇奎博士领导的美国制药行业研发高管科学家一流人才团队，建立一流的新药研发模式（内部研发引擎 + 强大的科研商务开拓吸引全球一流的创新）和能力（前端到后端“end-to-end” R&D 研发平台组），用来研发在国际上有竞争力的癌症治疗新药资产管线，为中国及全球患者提供中国制造的一流的新药，对创新驱动经济的战略做出贡献，同时创造高端就业机会，带来经济和社会价值.
福利待遇：
1. 工作时间：公司实行五天八小时工作制，所有员工依法享有法定假、婚假、产假、丧假以及法律要求的年休假等有薪假期；
2. 工资福利：员工享有膳食津贴，公司依照劳动法按时足额支付工资及加班费；
3. 社会保险：按国家相关规定为全体员工办理社会保险及住房公积金（五险一金），每年提供员工体检；
4. 文化福利：多元化国际工作环境 / 生日礼物 / 海外出差和培训机会 / 团队外出活动 / 各种兴趣社团 / 办公职员弹性灵活工作制等等；
5. 员工每年拥有灵活的调薪空间以及广阔的晋升空间。