北京招聘

Major Responsibilities

1. Execute the clinical data management strategy to ensure high quality, high value and timely clinical trial data that enable data exploration and analysis to drive portfolio decisions.

2. Partner with associate director of CDM to establish and streamline the internal CDM process and platforms to meet corporate needs.

3. Provides a study level data management CRO oversight and takes data management accountability for low to high complexity trials.

4. Perform quality control to DM CROs deliverables during trial setup, conduct and closeout.

5. Makes recommendations and influences decisions to trial processes or technical solution in line with business needs

6. Train and mentor junior staff

7. Maintain a positive, result oriented work environment, building partnerships and modeling team work, communicating to DM CRO and trial teams in an open, balanced, and objective manner.

Requirements/Qualifications:

Education: Minimum of a BS in life sciences degree or equivalent

Skills/Abilities:

1. Knowledge of clinical and pharmaceutical drug development process

2. Understanding of GCP and regulatory requirements as they relate to data management systems and activities

3. Understanding of Good Clinical Data Management Practices (GCDMP)

4. Understanding of database structures, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting

5. Understanding of clinical data system design / development / validation and system interoperability

6. Leadership skills (including in an outsourced environment)

7. Demonstrated project management skills

8. Strong communication and interpersonal skills

9. Strong organizational and analytical skills

10. Ability to work independently

11. Demonstrated ability to work effectively with external partners

12. Ability to negotiate and influence others across functional areas

13. Good written and oral English and Chinese communication skill.

Job Experience:

1. Minimum of 5 years of experience in Clinical Data Management

2. Medidata Rave experience preferred

3. Oversight DM CRO experience preferred

天境生物科技(上海)有限公司
天境生物由臧敬五博士领衔的创新药资深研发团队创建，是一家聚焦在肿瘤免疫和自身免疫疾病精准医疗领域的新药研发生物医药科技公司。
公司的核心竞争力在于早期研发、靶点发现和验证、工艺开发&临床前评价、质量科学&质量管理、早期临床研究的能力（包括临床一期和临床二期）。团队在创新药物靶点生物学、创新抗体药物分子结构研发以及创新药物的转化医学及临床研究方面的优势为公司建立一条具有国际竞争力的项目管线创造了基础。公司目前创新药管线含12个在研创新抗体药物项目。领先的创新药项目将在2017年3月申报临床研究并在台湾, 韩国及中国启动临床研究, 其它项目均已进入细胞株或工艺开发阶段。
公司从成立以来已经建立了广泛深入的国际合作, 如与瑞士FERRING公司合作独家引进开发Olamkicept。公司自主研发的全球创新药项目将在2018年进入中国及美国临床研究申报环节并计划在两地启动一期临床研究。