Global Study Lead

Highly Competitive
  1. Permanent
  2. Project/Study Manager (CSM/CPM)
  3. China
Shanghai, China
Posting date: 13 Sep 2019
CR.TT.25285_1568394307

A new biopharmaceutical company is seeking to recruit a Physician to their office in Shanghai. The organisation rapidly develops innovative drugs to meet the needs of global patients, focusing on the global development of drugs for autoimmune diseases. With a fast-developing pipeline of drugs entering the clinical stage in the near future, this position is the perfect opportunity to work a dynamic up-and-coming organisation that prides itself on its highly recognisable clinical development capability.

Job Responsibilities:

  • Lead the clinical trial team and coordinate and manage all activities related to clinical trials through the clinical trial team. In case of deviations from plan, provide options and escalate to Line Manager for decision making on what to do.
  • Plan, deliver, and manage clinical trial activities (start-up, operational conduct, and closure) according to SOPs and a responsibility agreement.
  • Collaborate with the Line manager and assigned CTMs/CRA allocated to the given trials.
  • Lead CRA team, coach people on clinical operation, permanence management, and personal development setting for subordinates.
  • Prepare project management plans and templates to be used for the trial including but not limited to, Monitoring Plan, Trial Risk Management Plan (handled in CTMS), Communication Plan, and ensuring the Clinical Trial Plan.
  • Liaise with clinical trial team members regarding trial design and protocol preparation.
  • Develop operational plan for the conduct of the clinical trial.
  • Communicate timelines, identify milestones, handle trial budget, and report progress for the clinical trials.

Skills and Requirements:

  • University degree in medicine or life sciences.
  • Extensive experience within clinical drug development.
  • At least 8 years of experience in clinical trial operation and at least 4 years of project management experience in global pharma or global vendors.
  • GCP certification.
  • Experience with multi-country and multi-centre studies.
  • Fluency in English.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Tom Tan at +86 21 51694101 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-TT1

#ClinicalResearch

close