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Title : SG- Assistant Clinical Inspection Readiness Leader -242
State : New Jersey   Date : Jan 4, 2021
Experience Level :  
Position Type : Assistant Clinical Inspection Readiness Leader      
Description
This position is for a leading pharmaceutical company. Below are the details of the engagement. If you are available and interested please send me your updated word resume & your expected hourly rate on W2 ASAP.
Looking forward to hearing from you soon.

Work Location: Bridgewater, NJ

Job Title: Assistant Clinical Inspection Readiness Leader

Duration: 6+ months (extendable) contract on W2


Summary: 

The Assistant Clinical Inspection Readiness Leader (Assistant CIRL) is part of the Clinical Quality Performance Team, under the Quality umbrella, and supports the Clinical Inspection Readiness Leader (CIRL) as part of the Inspection Readiness and PAI Preparation teams. The Assistant CIRL is responsible to support process and tool development/improvement/management initiatives and activities related to Clinical Inspection Readiness (IR), Pre-Approval Inspection (PAI) Preparation and PAI support and provides support to gathering/compilation of best practices and lessons learned. 

Duties & Responsibilities: 

1. Assists the CIRL acheive project deliverables for each major component of a transversal project, as assigned. 
2. Assists in the execution of the strategies to work with clinical cross functional departments to build ‘inspection readiness’ and identify and mitigate clinical quality risk with the clinical trial teams during study start up, conduct and close out/study reporting 
• Assist with meeting scheduling, agenda and minutes as required 
• Assist with Preparation & Quality Checks of documents as required 
• Assist in completion and management of IR reporting tools (Trial Summary, IPC Activity Trackers, etc) 
• Ensure documents are organized for ease of retrievability within IR sharepoint 
• Archives IR files as needed Supports the clinical teams to generate performance metrics and dashboards for status of inspection readiness reporting elements to management on a monthly basis or as needed. May be asked to lead ad hoc transversal team meetings based on experience and abilities 
3. Assists the sponsor monitor PAI preparation team and the preparation of the inspection staging room. Provides required support pre, during and post regulatory agency sponsor-monitor inspection with the goal to ensure clinical teams are prepared and trained and study documentation is quality controlled and available and all are able to withstand the scrutiny and questioning of a sponsor monitor pre-approval inspection. 
• Assist with meeting scheduling, agenda and minutes as required 
• Assist with Preparation & Quality Checks of documents as required 
• Assist in completion and management of PAI Preparation reporting tools (Frequently Requested Document Tracker, PAI Activity Trackers, etc) 
• Ensure documents are organized for ease of retrievability / Set up document staging 
• Supports back room and performs document management; QC, copying, filing, logging, scanning and CD preparation other duties as assigned during an inspection Support the generation of performance metrics and dashboards for status of inspection preparation and visibility of project level clinical quality risks to management on a monthly basis, during PAI preparation, or as needed. May be asked to lead ad hoc transversal team meetings based on experience and abilities 
4. Post event (inspection, audit, quality review, investigational panel or other identified sources), assists to gather, analyze & prepare lessons learned / best practices for the CSO platform, vaccines platforms and other key stakeholders, in collaboration with CQA, CQRM or other relevant stakeholders. Work in a mindset of being a learning organization. 
5. Assist to improve specifically the process for Inspection Readiness (IR) & PAI Preparation and assists to define and develop strategies to work with CSO cross functional departments to build ‘inspection readiness’ during study start up, conduct and reporting 
• Continual review of IR and PAI Prep process and tools 
• Support the roll out and continual update of inspection readiness requirements 
• Support and assist in the build of the Inspections Readiness & Preparation Sharepoint site 
• Update & reformat of PAI Toolkit (assist/participate in the cross functional review team, soliciting necessary feedback, updating tookit) 
• Consolidation & Improvement of current Inspection Readiness and PAI Preparation tools with a focus on automation (assist/participate in the cross functional review team, soliciting necessary feedback, updating tools) 
• Support and assist in the build of Inspection Readiness Expectations into a CSO end-to-end process map (e.g. web design for a “CSO Gateway”, expansion of the current “TO Gateway”) 
6. Continual review and maintenance of the Clinical Inspection Readiness - Inspection Readiness & Preparation Intranet and Sharepoint Sites 

Skills: 

Knowledge of Research & Development with experience in clinical operations, preferably within clinical trial management and/or GCP Quality and FDA/EMA GCP inspections. Knowledge of GCPs, ICH and SOPs. Experience with Sharepoint sites (developing & maintaining), Excel (good technical abilities), and Microsoft TEAMS The following skills are also of particular importance: 
Quality focused with a high degree of personal accountability and commitment 
Knowledge of international good clinical practices (ICH) and current regulatory requirements (FDA, EMEA) related/ applicable to the conduct of clinical trials, understanding of FDA Compliance Manual & EMA Compliance Manual 
Results driven with attention to detail and quality while overseeing and connecting with contributing stakeholders 
Excellent interpersonal and communication skills (written and verbal) 
Ability to drive results within established timelines 
Works proactively and takes initiative 
Ability to multi-task, handling a wide range of small, medium and long-term assignments in parallel and dealing with urgent issues as they arise with ability to prioritize assignments in accordance with assigned project deadlines 
Expert experience in various software and tool development (e.g. excel, databases, others) 
Competent in English (both written and verbal) to interact effectively in an international environment. 

Knowledge And Skills Desirable But Not Essential: 
Experience with FDA, EMA or other GCP regulatory inspections of sponsor, investigator sites, or CROs 
Experience working within a global team/environment 
Experience in web design and build.

Education/Experience: 

Associate degree or higher in a relevant scientific/health-related field. 
Minimum of 4 years experience in the pharmaceutical industry, with a minimum of 2 years experience in GCP clinical and/or quality operations-related roles (e.g., direct study management, monitoring, auditing)



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Many Thanks,   

Sree Kanth
Recruitment Manager
Sree@newageclinical.com

NewAgeSys, Inc.
Direct: 609-945-1736 Fax: 609-228-4079
600 Alexander Rd, Suite 3-3 
Princeton , NJ 08540 
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