• Study Manager Jobs in China - 25365707

  • Pfizer Inc.
  • China
  • Save Job
  • 5 - 8 Years
  • Posted : above 1 month

Job Description:

Protocol Development

Provide comprehensive operational input to the protocol design to ensure operational feasibility
Responsible for conducting the protocol feasibility prior to finalization of the CPEs, as appropriate
Generate study level ICD, as appropriate

Budget

Provide input to the generation of investigator grant budgets at the study level (identify required

budget components)

Initiate, review and ensure approval of the study start-up budget, including per subject and ancillary

investigator costs, and Clinical Trial Budget (or MPA)

Data Management/GCDS Interactions

Partner with GCDS to ensure set up of data capture tools (CRFs, EDC system, diary cards,

questionnaires, translations etc) to ensure completion within project deliverable timelines

Overall responsible for ensuring the study has efficient and effective data flows (for all types of study

data, including SAEs, endpoints, patient diaries, lab data, etc)

Subject Recruitment/Country Allocation/Site Selection/Start-up (as appropriate)

Conduct study level allocation including country and study level feasibility assessments to ensure

appropriate site selection in China

Develop study level recruitment/retention strategy/plan; oversee implementation of plan, including

site-level plans, recruitment/retention tools, and advertising materials

Oversee sites and site management to ensure timely site selection and site readiness (Clinical Site

Agreements, Ethics Committee approvals and regulatory documentation)

Partner with Project Planner and study team members to develop study level plans and processes to ensure alignment with overall Development Plan

Training/Investigator Meeting (as appropriate)

Develop the Monitoring Plan; ensure sites and CRAs are trained on Protocol-Specific aspects of the Study Monitoring Plan
Responsible for working with Clinician to ensure that CRAs are provided with appropriate training of protocol and knowledge of respective therapeutic area
Drive and/or contributes to investigator meeting strategy/agenda and responsible for overseeing

implementation by the project team; review meeting objectives/materials

Facilitate and presentation investigator meetings on study progress update and etc, as upon request of project team

Drug Supply

Collaborate with Supply Chain Lead to develop and complete the Request for Clinical Supplies
Work with the Supply Chain Lead to ensure that clinical trial drug supplies are ordered, produced,

labeled and supplied in a timely manner

Communications and Tracking Deliverables

Track progress to ensure all essential study materials, equipment and documentation are in place for

study start (eg, ethics and regulatory approval, budget, drug supplies, data collection tools)

Provide update of study status to study team as appropriate

Clinical Study Conduct

Subject Recruitment/Retention

Manage protocol-level subject recruitment and retention and take appropriate action to ensure targets are met

Quality & Compliance Management

Periodically review protocol deviations and collaborate with clinicians to manage protocol deviations

according to Pfizer SOP

Works closely with study team to ensure data quality requirements are agreed and met, prior to reporting
Perform required activities to ensure quality and completeness of Trial Master File and any additional

regulatory documentation

Work with quality assurance line to establish appropriate QC, audit and inspection plans Serves as

central point of contact for site and sponsor audits Supports the writing of appropriate audit

responses and ensures actions are completed

Leads and oversees the study risk planning process (eg IQMP)
Oversees operational metrics across study and manages trends and escalations
Ensures maintenance and accuracy of Standard Operating Procedures (SOP) log
Leads awareness and resolution of Significant Quality Events (SQEs) and escalations
Monitors and remediates quality metrics and completes remediation tracker
Conduct and report oversight activities, both remote and onsite visits according to Pfizer standards

Data Flow Management

Partners with GCDS and site management functional lines to ensure timely retrieval and

database entry of CRFs and other clinical study data and the distribution and resolution of data

queries

Coordinates endpoint collection, reconciliation and adjudication, when required
Coordinates data collection and cleaning for interim data locks (eg, DSMBs, Planned interim
analysis, Final Safety Updates, etc)
Ensures Quality Gate timing planning, and team readiness

CRO/Vendor Management

Effective management of external vendors including SMOs and CROs

Budget

Compiles components of protocol level budget
Approve up front or initial payments to investigators and vendors

Drug Supply

Work with Supply Chain Lead to ensure drug supply (including resupply) process timelines, risks

and issues are handled in a timely manner

Communications and Tracking Deliverables

Monitor cross-site performance and raise issues to CRAs for awareness
Responsible for distribution of protocol level to CRAs and then ensure investigational sites are fully informed in timely manner
Manages study team communications to ensure cross-functional connectivity among study team members and supporting functional lines

Clinical Study Close-out

In close partnership with the CRAs to ensure site closeout activities are completed
Responsible for the collection and consolidation of the Protocol Deviation Logs
Accountable for study close out; support GCDS in database lock and release activities, ensuring all

timelines and quality goals are met

Contributes information regarding study conduct, as required, to ensure effective and timely study

reporting Participates in review of study report, as appropriate

Responsible for inspection readiness at a study level with site facing activities such as self-inspection remaining the responsibility of the Study Management group

Technical Competencies Competency Detail / Comments (specific skills, etc) Scientific and drug development expertise
Clinical study expertise
Problem solving/Decision Making
Organizational skills
Communication skills
Project/process management
Administrative excellence
Clinical/Scientific aptitude
Technology management
Budget / expense management
Understanding of scientific/clinical principles,

and ability to work across different therapeutic

areas Knowledge of working with complex and

novel emerging technologies, and interpret and

incorporate them within the context of a clinical

trial

Extensive knowledge of clinical development

process including in depth knowledge and

understanding of the principles of GCP

Ability to understand and influence Site

Investigators/Key Opinion Leaders on non-medical related issues

Working knowledge of the principles and

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Bio Tech/R&D/Scientist
Role : Clinical Research
Salary : As per Industry Standards
Deadline : 09th Jun 2020

Key Skills:

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