Publicis Touchpoint Solutions, inc.

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Clinical Research Operations Manager - Tokyo

at Publicis Touchpoint Solutions, inc.

Posted: 12/3/2017
Job Reference #: TAR000318
Keywords:

Job Description

Job Title Clinical Research andOperations Manager

Location: Field based, project reportingline into Clinical Research and Operations Director

 

JOB DESCRIPTION

The Clinical Research and OperationsManager (CROM) function as a remote site-based member of the larger ClinicalOperations Study team. The purpose of the CROM is to help ensure seamless studyset up, maintenance and close out of the assigned programme in Asia. Dutiesinclude:

 

During the study start-up phase

Attend site initiation visits

Provide disease area/product backgroundtraining for site staff

Answer questions on protocol/studydesign & feedback to the team

Identify suitable replacement or rescuesites

During the study maintenance phase

For site staff turnover: provide diseasearea/product background/protocol training for site staff

Provide protocol amendment training tosite staff

Develop an understanding of treatmentpathways and local standard of care, to inform recruitment strategies and tofeed back to the Clinical team

Support development of site-specificenrollment strategies and tactics (incl. advertisement)

Support development of site-specificretention strategies and tactics

Develop and coordinate localinvestigator meetings

Support CRAs in resolution ofsite-specific monitoring issues

Attend booster/co-monitoring visits (egin case of protocol amendments, enrollment challenges)

Support resolution of site-specificvendor-related issues (for example, imaging, labs, ECG, CRF Health, pharmacy)

Data quality / database lock / close outphase

Ensure site is meeting agreed uponbenchmarks for data entry, image submission

Alleviate CRA roadblocks for timelydatabase lock (unresolved queries, missing data, missing images, PI sign off)

Other

Maintain site contact records (contacttemplate), follow up open issues with sites in writing and submit all documentsto trial master file

Communication/escalation of issuesrelated to study conduct and quality to CRO and/or internal team and proposecontingency plans to CRA to resolve

Ensure requests for medical advice forindividual patients are referred to the study-assigned Medical  Monitor for resolution

Attend regularly scheduled CROM meetingsand relevant study team meetings as assigned by line manager

Monitor site-specific performancemetrics and address emerging issues in collaboration with CRA

Support site audit/inspection activitiesas requested by company compliance/auditing groups

Support serious suspected non-complianceremediation activities per company process

Coordinate company/investigatorinteractions at conferences

As requested by Company Medical Affairsor Clinical Sciences: support external expert identification and coordinate duediligence paper work for advisor contracts

As requested by Company Medical Affairsor Clinical Sciences: support external expert relationship development

 

JOB REQUIREMENTS

Engage clinical trial sites to evaluateand develop opportunities to optimize participation and enrolment in company clinicaltrials

Maintain command of latest scientificdata relevant to the role, knowledge of assigned study protocols relatedcompliance and policy and procedure information

Engage Key Medical Experts in thetherapeutic area as needed to fulfill objectives of the development program

Act as a scientific resource forclinical trial sites and external experts within assigned therapeutic area andgeography

Refer unsolicited medical inquiries tothe study-assigned medical monitor

Collaboration with Clinical Operationscolleagues, including reporting of designated or discovered informationimportant to trial execution

Support the CRO in the management ofissues related to suspected serious non-compliance or any other operationalissue that may impact patient safety or data integrity

Ensure company policies, principles, andfinancial controls are maintained with integrity and professionalism

Frequent travel (including occasionalweekends) with overnight trips as necessary to accomplish above objectives

 

Education

Masters in lifescience subject required

MD, PhD or PharmD ideal

 

Experience

Required: at least 6 years of clinicalresearch experience (either as site investigator, at a CRO or at a sponsorcompany)

Beneficial: at least 3 years of clinicalresearch experience at a sponsor company

Track record in designing and/orimplementing successful patient recruitment or retention strategies

Strongly preferred: Excellentunderstanding of local medical practice for management of lung cancer

Self-starter, ability to workindependently, ability to work effectively in remote teams

Excellent written and oral communicationskills

Required: fluent in local language andin English

Beneficial: fluent in a language used ina neighboring country