Local Study Team Leader 面议 申请该职位

Local Study Team Leader


面议 全职| 招聘:1人 | 5-8年| 硕士| 2019-08-16发布




Plan and Lead the Delivery of all components of a clinical study to time, cost, and
quality from Study Specifications through study closeout activities and Clinical Study Report.

To lead Local Study Team at country level to deliver committed components of clinical studies
according to agreed resources, budget and timelines complying with DZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. Provide co-monitoring to CRAs to ensure study quality reaching/above global level. Develop and maintain excellent working relationships with external and internal customers to ensure the smoothly and timely delivery of clinical studies.

In addition to leading LST(s), LSTL is expected to perform site monitoring if needed. As part of the flexible capacity model it is expected that LSTL manages both roles.

LSTL is responsible to ensure that sites are identified, site qualifications performed,
set up, initiated, monitored, closed and documentation archived.

Overall responsibility for the study commitments within the country, for timely delivery of data to required quality.

Contribute and support global study lead on overall study deliveries.

Lead Local Study Team(s) consisting of monitors and study administrator(s).

Lead and optimise the performance of the local Study Team(s) at country level ensuring compliance with DZ Procedural Documents, ICH-GCP and local regulations
and to update other study team members on study matters

Lead development of Local Monitoring Plan as per Targeted Monitoring guidance from
respective Study Team.

Contribute to review of monitoring visit reports and pro-actively advice the Monitor(s) on
study related matters.

Perform any required  co-monitoring & QC visits with study monitor(s)

Proactively identify and facilitate resolution of complex study problems and issues.

Organise regular Local Study Team meetings on an agenda driven basis.

Actively work towards achieving good personal relationships with all local Study Team
Report study progress/update to the SMO Study Leader/Team.

Contribute to patient recruitment strategy including regular communication with concerned
Investigators as necessary.

Communicate and co-ordinate regularly with National Co-ordinating Investigator / National
Lead Investigator on recruitment and other study matters.

Coordinate the process for selection of potential Investigators considering capability,
competence, etc, of the Hospitals/sites.

Plan and lead national Investigator meetings, in line with local codes

Assist in forecasting study timelines, resources, recruitment, budget, study materials
and drugs.

Work in close coordination with Study Drug Coordinator to create a robust Drug
Consumption Plan.

Ensure completeness of the Study Master File and ensure essential documents are sent.

Ensure local Serious Adverse Event (SAE) reconciliation takes place.

Facilitate translation of documents (ICFs, patient diaries, participation cards, etc)
through external providers.

Ensure timely submission of proper application/documents to EC/IRB.

Work together with Regulatory Affairs to ensure timely delivery of proper application/documents for submissions to Regulatory Authority.

Set up and maintain the study in CTMS at study country level.

Ensure accurate payments related to the study are performed.

Participate in training and coaching new members of the Local Study Team ensuring compliance with ICH/GCP and DZ Procedural Documents.

Ensure that all study documents are ready for final archiving and sign-off completion of local part of the Study Master File.

Plan and lead activities associated with audits and regulatory inspections

Provide input to process development and improvement.

Provide regular information to Line Managers on study and planned study milestones/key issues.Update Line Managers about the performance of the monitors/CRAs.Ensure that study activities at country level comply with local policies & code of conduct.

Minimum Requirements and Preferred Background
Minimum University degree and / or equivalent, preferred in biological science or healthcare-related field.

Minimum 4 years experience in Clinical Operations or other related fields (Medical Affairs-led studies or Academic-led studies)

Excellent knowledge of spoken and written English.

Good ability to learn and to adapt to work with IT systems.


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