Clinical Project Manager（临床项目经理）

该职位来源于猎聘 We are currently seeking a Clinical Project Manager based in Shanghai or Guangzhou / Foshan to join our medical and clinical team. This person will be responsible for ensuring project plans are executed according to planned quality, timelines and cost. He or she will oversee the daily operation of various development programs, collaborate with colleagues from medical / DMPK / CMC/ regulatory teams, and facilitate timely decisions to ensure alignment and deliverables. Reporting to Senior Director of Clinical Development, this position offers an excellent opportunity for someone who enjoys working in a fast-paced company where he or she will have the opportunities to take ownership of his or her own work, enhance his or her current abilities and have an exciting and rewarding career in drug research and development while making a positive impact to lives of cancer patients. Responsibilities

• Serve as the leader of clinical study project team to contribute to the accomplishment of trial objectives outlined by the global clinical development plan
• Participate in all aspects of project management, including scope, cost, time, quality, safety, communication, risk, vendor, stakeholder, and scenario planning at a global scale
• Oversee and manage CROs, other third-party vendors and contractors, to ensure delegated outsourced activities are delivered according to contract
• Facilitate contract and budget negotiations with clinical sites and vendors
• Contribute to the development and active management of study-specific patient recruitment strategies, project and keep track of study enrollment / drug supply / related resources needs
• Collaborate with multiple study functions at CROs and vendors, including data management and EDC, drug supply chain, biostatistics, medical and pharmacovigilance, regulatory, etc.
• Participate in developing critical clinical trial documents such as protocols, deviation lists, informed consent forms (ICFs), country and site contract / budget templates, master labels of investigational products, database specifications, drug supply and bio-sample management plans, TMF, and CSRs
• Develop study tools, guidelines and training materials, or oversight the deliverables from CRO
• Lead the trial information/results registration activities on regulatory platforms (e.g., clinicaltrials.gov), and support the publication plan of studies
• Coordinate planning and execution of investigator meetings and various trial advisory committees (e.g. Steering Committee), may be accountable for driving agenda and content for the meetings
• Provide routine updates on project status, proactively identify risks / issues, and develop and implement risk mitigation / issue resolution plan to ensure operational effectiveness

Qualifications

• Bachelor or Master’s degree in scientific, biological, and life sciences
• At least 5 years’ experience in the biopharmaceutical industry and clinical trial related activities
• Understanding the process of drug development, with experience in global clinical operations preferred, with experience in biotech / CRO preferred
• Knowledge and familiarity with industry standards including ICH guidelines, GCP and regulations
• Performance driven with ability to work independently, with proven operational and tracking skills
• Excellent organizational and priority management skills
• Exceptional interpersonal and communication skills with conflict resolution and consensus building abilities
• Highly collaborative and works well in a team environment, especially able to work effectively with colleagues from different cultures, backgrounds and geographies