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China Dev

Pfizer


Location:
Chaoyang Qu, Beijing Shi 100096
Date:
02/01/2018
2018-02-012018-03-04
Pfizer
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Job Details

Position Purpose:



An experienced role. To collaborate in the identification and drive the selection of investigator sites with input from other cross-functional groups. To monitor investigator sites in compliance with Pfizer SOPs, ICH/GCP and local laws so site performance targets are achieved and the company's image with its external customers are enhanced. To drive quality standards by acting as a mentor and providing support to less-experienced colleagues. To oversee and supervise contract and Pfizer CRAs as required. To support the Lead of Site Management by performing specific operational tasks as defined by business need.







Organizational Relationships:



Reports to the Monitoring Lead



Dotted line reporting to protocol specific Study Manager







Resources Managed (budget and FTEs):



None







Primary Duties (fundamental components of role-both strategic & operational):







Monitoring



Conduct SDV and ensure clinical trials data are submitted to data management in a timely fashion.



Identify issues that may impact on the conduct of the study and ensure appropriate closure of all issues.







Management of Investigator Sites



Proactively manage a number of studies and investigator sites commensurate with experience, so that studies are run efficiently and key study objectives are met (pro rata with available monitoring time).



Ensure studies are run in line with ICH/GCP, local laws and Pfizer SOPs and procedures.



Ensure patient safety is maintained and all safety issues are reported correctly according to all relevant local and international regulatory requirements.



Inform the PI and site staff of all issues.



Agree and develop corrective and preventative actions with PI and site personnel to close all open issues.



Responsible for all aspects of site management from collaboration on site selection to study closeout with appropriate mentoring and support.



Train site staff on the protocol, protocol amendments and Pfizer processes.



Understand the product, the protocol and the therapy area in sufficient detail to be able to have appropriate discussions with the investigator team.



Interact with health care professionals in a manner, which enhances Pfizer's credibility with the customer.







Data Quality



Ensure that data monitored meets target quality standards.



Ensure that data are entered into Pfizer systems in a timely manner.







Reporting



Report on progress of all studies at the investigational site after each visit to ensure that all relevant personnel are aware of progress against plan and any issues that have occurred.



Ensure all issues are correctly identified and catalogued.



Proactively manage issues to appropriate closure.



Maintain accurate site-level information on corporate clinical trials registry.







Documentation



Obtain critical information to enable generation of IIP documentation.



Assist CTA in gathering IIP documentation where required to ensure timely site set up.



Maintain the SMF and SMF log.



Maintenance of ELARA and/or PTMF to ensure audit trail is complete and accurate.



QC relevant documents in ELARA and/or PTMF in a timely manner.



Generate site monitoring reports.



Maintain all appropriate monitoring logs.







Mentoring



Mentoring and supporting less experienced colleagues.



Mentoring, Coaching and supporting other team members.







Supervision of Contract CRAs (as required)



Involvement in selection and supervision of contract CRAs (cCRAs) as required.



Ensure induction and appropriate Pfizer specific training of cCRAs is undertaken.



Plan cCRA resources in such a way that their time is utilised optimally.



To lead, motivate and drive the performance of cCRAs to achieve agreed objectives.



To ensure that monitoring and site management activities are carried out to the highest standards in accordance with the appropriate regulatory and legal framework and company SOPs.



Provision of ongoing feedback of performance issues to agencies/MSP.







Performing specific delegated tasks



Perform designated tasks, delegated from the Monitoring Lead to the required standard.







CRO oversight



To support oversight of monitoring by accompanied visits with CRAs including CRO/FSP/contractor staff as required.



Provide feedback to CRAs and Study Managers on issues identified.



Use findings and observations from oversight activities to proactively drive higher quality standards.







Training & Education



Required: Preferred:



Life Science/Nursing graduate or equivalent with at least 5 years of Clinical Monitoring/Site Management experience



Experience of working across a variety of therapy areas and trial phases



Demonstrated ability to adopt and promote new processes and systems



Full driving license Experience of mentoring/oversight



CRA management experience possibly via project management







Training and Relevant Experience



Computer literacy (word processing and spreadsheets)



Thorough knowledge of ICH/GCP and relevant international and local regulations relating to Clinical Research



Technical Competencies



Competency Detail / Comments (specific skills, etc.)



Quality requirements Demonstrated knowledge of quality and regulatory requirements across a range of different countries.



Drug development process Demonstrated knowledge of clinical trial methodology and the drug development process, related to monitoring clinical trials, GCP, FDA, or country-specific regulatory environment.



Scientific/technical/administrative excellence Demonstrated success in prior scientific/technical/administrative management roles.



SOP Compliance Maintain knowledge and expertise on all relevant SOPs.



Instructional design, development and assessment Demonstrated application of training principles, in clinical, technical and general areas.



Demonstrated ability to assess, design, develop and evaluate training, and guide/assist SMEs to do the same.



Training/adult learning design and delivery experience considered a plus.



Project and process management Demonstrated ability to manage projects and cross-functional processes.



Communication and presentation skills Ability to communicate effectively and appropriately with internal & external stakeholders.



Systems technologies Understanding of the state of the art technologies in order to support the evaluation of incorporating them into the organization.



Administrative excellence Attention to detail evident in a disciplined approach to document training, adherence to SOPs, forecast to spend tracking, metrics, etc.



Organisational skills Works independently. Receives instruction primarily on unusual situations.



Ability to organize tasks, time and priorities of self and others; ability to multi-task.







Behavioral Competencies



Competency Detail / Comments (specific skills, etc.)



Understanding stakeholder needs Seeks to develop an integrated view of key colleague issues to shape decisions and strategy development.



Achieving quality and excellence Looks across and outside the organization for better ways of working - receptive/willing to others ways of thinking.



Initiating and Implementing change Proactively manages change by identifying opportunities and coaching self and others through change.



Interpersonal communications Displays sensitivity to manage relationships and ability to build collaborative working relationships with colleagues and associates both within and external to the organization.



Influencing Demonstrated ability to introduce new ideas and get them implemented.



Effectively overcoming barriers encountered during the implementation of new processes and systems.



Teamwork Is visible and well recognized across the Area for promoting collaboration across functional and geographic boundaries.



Learning organisation Seeks to clarify feedback non-defensively to understand required improvement.



Customer Focus Identifies and builds effective relationships with customers and other stakeholders.



Cultural awareness and sensitivity Works well across country and area boundaries, respecting communication and cultural differences in interpersonal relationships.Monitoring



Conduct SDV and ensure clinical trials data are submitted to data management in a timely fashion.



Identify issues that may impact on the conduct of the study and ensure appropriate closure of all issues.



Management of Investigator Sites



Proactively manage a number of studies and investigator sites commensurate with experience, so that studies are run efficiently and key study objectives are met (pro rata with available monitoring time).



Ensure studies are run in line with ICH/GCP, local laws and Pfizer SOPs and procedures.



Ensure patient safety is maintained and all safety issues are reported correctly according to all relevant local and international regulatory requirements.



Inform the PI and site staff of all issues.



Agree and develop corrective and preventative actions with PI and site personnel to close all open issues.



Responsible for all aspects of site management from collaboration on site selection to study closeout with appropriate mentoring and support.



Train site staff on the protocol, protocol amendments and Pfizer processes.



Understand the product, the protocol and the therapy area in sufficient detail to be able to have appropriate discussions with the investigator team.



Interact with health care professionals in a manner, which enhances Pfizer's credibility with the



customer.



Reporting



Report on progress of all studies at the investigational site after each visit to ensure that all relevant personnel are aware of progress against plan and any issues that have occurred.



Ensure all issues are correctly identified and catalogued.



Proactively manage issues to appropriate closure.



Maintain accurate site-level information on corporate clinical trials registry.



Documentation



Obtain critical information to enable generation of IIP documentation.



Assist CTA in gathering IIP documentation where required to ensure timely site set up.



Maintain the SMF and SMF log.



Maintenance of ELARA and/or PTMF to ensure audit trail is complete and accurate.



QC relevant documents in ELARA and/or PTMF in a timely manner.



Generate site monitoring reports.



Maintain all appropriate monitoring logs.



Mentoring



Mentoring and supporting less experienced colleagues.



Mentoring, Coaching and supporting other team members.



Performing specific delegated tasks



Perform designated tasks, delegated from the Monitoring Lead to the required standard.







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Apply on the Company Site
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