Site Activation Partner
4 days ago
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
RemoteWork :
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