Site Activation Partner

4 days ago


New Delhi, India Lifelancer Full time

About thejob

The Site Activation Partneris responsible for leading or supporting operational activitiesfrom startup to closeout for assigned studies and investigatorsites to ensure compliance with study timelines and in accordancewith prevailing laws Good Clinical Practices and Pfizer standards.Responsibility within a country and may span over more than onecountry depending on the geographical region and businessneeds.

RoleResponsibilities

Clinical TrialSite Activation

Initiate and coordinateactivities and essential documents management during startuptowards the compilation of a highquality Investigator InitiationPackage (IIP) leading to approval for site initiation

Provide support to resolve issues or concerns and timelyescalation of Site issues where applicable

Prepare validate and submit regulatory documents such as completedIIP IRB approval forms FDA 1572/Attestation Form for internalregulatory approval within required timelines

Manage and coordinate with other supporting roles to ensure timelysite activation and operational activities.

Support the compilation of the Central Investigator Review Board(IRB) package and submissions to approval of the study (whereapplicable) and other committees as per countryrequirements

Coordinate the timelycommunication documentation and responses between Pfizer andCentral Ethics committee to bring clinical study to approval(country dependent)

Support investigators siteswith local IRB workflow from preparation submission throughapproval

Assist with the preparation handlingand distribution of clinical documentation and reports according tothe scope of work and standard operating procedures.

Support implement activities in Shared InvestigatorPlatform to align with Pfizer strategy as it relates to therole

Clinical TrialsConduct

Post site activationinitiate and coordinate activities and essential documentsmanagement with the investigators sites towards the compilation ofa highquality documents and updates through the life cycle of astudy such as the documents management for protocol amendments FDA1572/Attestation revisions Ethics Committee annual approvals andother activities required during study conduct

Ensure maintenance of IRB/Ethics and other committees activities asapplicable

Responsible for timely filing ofdocuments to Trial Master File and assisting with periodic qualityreview of study files for accuracy and completeness

Accurately update and maintain clinical trial systemsthat track site compliance and performance within projecttimelines

Supports investigator sites and studyteams in preparation for and providing responses to site audits /inspections

Internal ExternalCommunication

Maintain ongoing contact andcommunication with the study team and respond promptly to studyteam and investigator site requests

Providefunctional updates on a country and site level asrequired

Establish tools for efficient updatesto study team as needed regarding site status issues delaysapprovals

Disseminate Central or Local EthicsApproval to study team and Investigator Sites whereapplicable

Communicate Local sites approvals tostudy team members and stakeholders

Clinical Trial SiteSupport

As needed performawareness session with site personnel on Pfizer requirements and toensure ongoing compliance with study documentation in accordancewith prevailing laws Good Clinical Practices and Pfizerstandards

Identify and resolve investigatorsite issues within required timeframes; align with study team andlocal country colleagues on corrective and preventative actions toclose open issues and to prevent recurrence / persistence ofissues

Additional Responsibilities:

A good understanding of the Site Activation requirementsand processes within the country/region and be able to learn andpotentially implement in more than one (1) country

May be assigned as Site Activation Partner Point ofContact (PoC) on a study conducted in multicountry

May be assigned as an SME on a system and/or process andrepresent the SAP function as applicable

Mayrepresent the SAP role on global initiatives

Able to act as an SME on projects and initiatives asrequested

Support the mentoring of new hires onprocesses/ systems

SystemsTools

Ability to use and learnsystems and to use independently

MicrosoftSuite

Clinical Trial Management Systems(CTMS)

Electronic Trial Master File

Electronic Investigator Site File (e.g.Florence)

Document exchange portals

Shared Investigator Platform

EthicsNational Networks and Governing Bodies Portals and platforms (asneeded)

Qualifications /Skills

BASICQUALIFICATIONS

BS/BA or bachelors degree inLife Sciences preferred

26 years relevantexperience in Clinical Site Management.

Experience working in the pharmaceutical industry/or CRO in studysite activation is an asset

Knowledge ofclinical trial methodologies ICH/GCP FDA and Global and localcountry regulations

Must be fluent in Locallanguage and in English. Multilanguage capability is anasset

For individuals based in Canada:Bilingualism (French English) is an asset

Effective verbal and written communication skills in relating tocolleagues and associates both inside and outside of theorganization

Good technical skills and abilityto learn and use multiple systems

Physical/MentalRequirements

Demonstratedknowledge of clinical research and development processes Keyoperational elements of a clinical trial and ability to gaincommand of process details

Understand thequality expectations and emphasis on right first time. Demonstratecompliance with all applicable company regulatory and countryrequirements. Attention to detail evident in a disciplinedapproach

Ability to work independently and alsoas a team member

Ability to organize tasks timeand priorities ability to multitask

Understandbasic medical terminology GCP requirements and proficient incomputer operations

ORGANIZATIONALRELATIONSHIPS

Global StudyManager and StartUp Project Manager Global StudyClinician

Local Site Relationship Partners andDirector Clinical Site Operations Clinical Trials Manager and otherLocal Roles

Global Investigator InitiationPackage (IIP) Regulatory Group

Local RegulatoryManager CTA Hub and CTA Submission Managers

Site Intelligence Team

Contractspecialists

Investigators Sites

Country Ethics Committee representatives

Other governing bodies representatives

Local provincial/States and nationalnetworks

Lifelancer( ) is a talenthiring platform in Life Sciences Pharmaand IT. The platform connects talent with opportunities in pharmabiotech health sciences healthtech data science and ITdomains.

Please use the below Lifelancer linkfor job application and quickerresponse.

/jobs/view/361be88bef8de67827fd488996fcfe77

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