TechD ata is hiring Executive Assistant, Quality Assurance Associate-CAPA , Pharmacovigilence Manager, Outcome Research Statistician (Evidence Based Medicine, econometrics/Psychometrics) , Biostatistician, SAS Programmers(Some can be telecommuting), Drug Safety Specialist, Trial Safety Manager in Central and Northern NJ . Please see below requirements and send your resume to: or . TechData is a leading provider for temporary and permanent positions in the pharmaceutical industry. TechData offers very competitive pay rate and benefits .
Executive Assistant
Contract Position – Potential contract to hire
Bedminster, NJ
The Executive Assistant (EA) will provide administrative support to the legal department. The incumbent will need to demonstrate a high level of professional and interpersonal skills in dealing with time sensitive and confidential information.
Manage calendars. Schedules/accepts complex meeting requests including teleconferences, video conferences and web-ex meetings and handle conflicts and follow-up as needed. Proactively schedules routine meetings. Arrange for catering and prepares meeting materials. Organizes and coordinates travel itineraries and expense reimbursements
Telephone/Fax: Receives and initiates complex and confidential calls. Handle priorities appropriately.
Online Contract System:
Assistant in requesting confidential agreements (CDAs), master service agreements (MSA) and consulting services agreements (CSA’s).
Assist in logging executed agreements into Axxerion.
Assists with other projects as assigned
QA-CAPA
Hold routine CAPA Board meetings to assign sponsors, resolves issues and determine when to elevate CAPAs appropriately.
Direct personnel in the identification of issues from the review and analysis of complaints, trend data and other sources and ensure all CAPAs have been identified and assigned according to procedures.
Manage the automated electronic management system for CAPAs including workflows, administrative duties and SOPs while ensuring timely and compliant review an documentation of CAPAs.
Assist the Complaints Manager with clinical and customer complaints processing activities and administrative duties.
Additional Info: Can you describe a “Day in the Life”: Manage CAPA follow up, interact with various sponsors on critical or overdue CAPAs, train employees on CAPA procedures/systems, administrative duties and assist the Complaints manager with follow up activities. Top three duties: CAPA admin, lead CAPA Review Board, trending, assist with customer complaints Physical requirements: None Soft skills: good communication skills and ability to negotiate with vendors Supervision level: works independently Pace: fast Decision making requirements: able to determine when to elevate issues
h. Education requirements:
Minimum 5 yrs QA experience
Bachelor degree in scientific or related field
5 – 10 yrs pharmaceutical, Biotech or device
Significant recent experience with Device CAPA and associated regulations
Experience with automated Quality Management Systems
Additional Info Work Location (city/state) – Bedminster, NJ Department/Project IDs – NA Dress Code – Business casual Assignment Length (#mos) – 6 – 12 months Will this go perm, or is it contract only? Possibly but no guarantee How quickly does this need to be filled? immediate Is this being worked on internally? No
Pharmacovigilence Manager
This req is being reopened. Please submit additional candidates with Seeking a Healthcare professional (Rph, PharmD, RN) with at least 2 years’ experience in case processing and previous experience working with data migration from one safety database to another
SAS Programmer (Some positions can work from home – long term)
Job Description:
Statistical Programmer
Review protocols, statistical analysis plans and case report forms, and provide SAS data specifications for clinical trials
Ensure programming deliverables are consistent and comply with study protocols, statistical analysis plans and case report forms
Work under the supervision of project statistician to coordinate with data management and clinical operation to ensure quality of clinical trial databases
Develop standard programs to facilitate general programming requirement in clinical trials
Provide ad-hoc analysis programming to explore repository databases and to support publications
Ensure implementation of corporate standardized programming conventions and working guidance
CANDIDATE‘S PROFILE
Education / Professional experience
Master’s or equivalent degree in Biostatistics, Statistics, Epidemiology, Mathematics, Computer Science, Life Sciences or related field
5+ years of pharmaceutical experience
Skills & competencies
Good interpersonal, communication, problem solving, and analytical skills
Work independently with minimum or none supervision
Ability to collaborate and communicate with cross-functional team members
Flexible and excellent ability to work on multiple studies with competing priorities
Expert technical skills in SAS Base/Macro/Graph/Stat
Excellent knowledge of CDISC-compliant SAS data structures and other related regulatory guidance
Outcome Research Biostatistician 1:
The EBM (Evidence Base Medicine) biostatistician provides statistical expertise for all observational research project sponsored by the US Evidence Based Medicine (EBM) in protocol development, Statistical Analysis Plan (SAP) preparation and study report. The role needs to ensure that appropriateness of study design, sample size and statistical methodologies are used and adherence to the established standards and SOPs. The role manages the timely execution of statistical and research methodological components of EBM study protocols in order to meet project objectives and has a thorough understanding of current requirements for statistical standards.
Roles/Responsibilities
Utilize statistical knowledge of and expertise to provide statistical support for EBM studies, with a main focus of real-world observational studies, database examples:
1)US medical and pharmacy claims databases (e.g. MarketScan); 2) US medical record databases (e.g. GE Healthcare); 3) US government public use databases (e.g. NHANES, MEPS)
Participate in study concept, protocol and SAP development and ensure appropriateness of study design, sample size and statistical methodologies proposed.
Specify the structure of the datasets that will be delivered for statistical analysis to ensure that the structure follows any existing company standard for databases pooling.
Mock-up, review, and approve tables, listings and graphs specifications.
Actively participate in project/study team meetings
Establish/negotiate timelines for completion of study-related statistical activities. Ensure the study timelines are met.
Conduct observational data analysis, include data management, statistical programming, interpretation of analyses results, and write-up/review the corresponding sections of EBM study report.
Produce analysis datasets, listings, tables, and figures for research projects, according to specifications, while maintaining documentation and complying with pre-defined project / study standards.
Provide oversight of the biostatistics-related activities for EBM studies subcontracted to a CRO:
Oversee the CROs work on the preparation of analysis plans, development and validation of computer algorithms for inferential analyses, statistical writing of study reports, and other outsourced analyses as appropriate.
Perform quality control procedures to ensure that statistical deliverables conform to the requirements outlined in the SAP
Skills
Working knowledge and experience with bio statistical analysis and SAS programming.
Excellent oral and written communication skills in English are a must.
Prior work experience in epidemiology, health economic and outcome research, or clinical research area is a plus.
Specific experience and understanding of outcomes research, drug development is an asset
Familiarity with observational databases desirable; database examples
US medical and pharmacy claims databases (e.g. MarketScan)
US medical record databases (e.g. GE Healthcare)
US government public use databases (e.g. NHANES, MEPS)
Keywords
Education MS or Ph.D. in Statistics or related field
Minimum 3-year experience in pharmaceutical research or equivalent
Outcome Research Position 2:
Roles and Responsibilities: Prepare, verify, and manage research data sets from administrative health insurance claims, electronic medical record databases, randomized clinical trials, or other sources as per provided specifications. Perform ad-hoc queries, statistical analysis, modeling, and reporting using SAS. Conduct analytic quality assurance procedures and creation of final deliverables. Develop SAS macro libraries to standardize disease identification, cohort constructions, mapping of healthcare resource utilization and expenditures for product value propositions. Construct drug coding systems to support database activities for key therapeutic R&D and brand LCM activities, and establish and maintain a repository of the coding systems for therapeutic medications, diagnostic or surgical procedures and drug delivery systems. Provide timely analytic support for abstract and manuscript development and submissions to medical/scientific congresses or publications.
Skills: Working knowledge of healthcare industry and drug development Strong expertise in SAS programming including Proc SQL, SAS macros, tables/listings/graphs and SAS/STAT Strong data management skills and demonstrated record of working with large real-world databases Knowledge of R, OpenBUGS, VBA or other analytic packages is a plus Ability to perform statistical, analytic and programming tasks with high efficiency and limited guidance Ability to plan, organize, and work on multiple tasks simultaneously and in multidisciplinary teams. Self-motivated with ability to meet deadlines.
Education:
Advanced degree in statistics, econometrics, psychometrics, or related quantitative sciences plus >4 years of experiences in claims database analytic work and statistical modeling
SAS Programmer (Some positions can work from home – long term)
Job Description:
Statistical Programmer
Review protocols, statistical analysis plans and case report forms, and provide SAS data specifications for clinical trials
Ensure programming deliverables are consistent and comply with study protocols, statistical analysis plans and case report forms
Work under the supervision of project statistician to coordinate with data management and clinical operation to ensure quality of clinical trial databases
Develop standard programs to facilitate general programming requirement in clinical trials
Provide ad-hoc analysis programming to explore repository databases and to support publications
Ensure implementation of corporate standardized programming conventions and working guidance
CANDIDATE‘S PROFILE
Education / Professional experience
Master’s or equivalent degree in Biostatistics, Statistics, Epidemiology, Mathematics, Computer Science, Life Sciences or related field
5+ years of pharmaceutical experience
Skills & competencies
Good interpersonal, communication, problem solving, and analytical skills
Work independently with minimum or none supervision
Ability to collaborate and communicate with cross-functional team members
Flexible and excellent ability to work on multiple studies with competing priorities
Expert technical skills in SAS Base/Macro/Graph/Stat
Excellent knowledge of CDISC-compliant SAS data structures and other related regulatory guidance
Contract Biostatistician (Some can be remote)
Consultant will provide statistical supports for Phase 2/3 clinical studies. Activities include preparing study protocol (drafting statistical section and integrating it within the protocol), reviewing case report form (CRF), performing statistical activities supporting clinical trial randomization according to relevant SOPs, attending the clinical trial meetings, drafting data review and surveillance plan (DRSP) and conducting the data review meetings, developing statistical analysis plan (SAP), and preparing shells for tables, listings, and graphs (TLG). The candidate will work closely with the programmers to define and document derived variables needed to produce planned TLG; He/she will perform statistical analysis according to the SAP, validate analysis programs, review TLG, prepare statistical methods and results sections for the clinical study report (CSR), and work with the CTT to move the CSR through review / approval process.
Understanding of statistical concepts and techniques; Familiarity with clinical trial concepts, such as randomization, type I / II error, estimation of treatment effects, sample size calculation, etc.; Ability to program statistical analyses; Ability to adapt and implement statistical analysis plans (SAP); Competency in written and spoken English. Consultant must have excellent statistical and communication skills, attention to detail and work well in a team environment that includes SAS programmers, other statisticians, clinical, and data management colleagues.
A PhD in Statistics or Biostatistics with at least 3 years pharmaceutical experience or a MS in Statistics or Biostatistics with at least 4 years pharmaceutical experience is prefered. SAS programming experience is a must.
Drug Safety Specialist
Ensuring that individual Adverse Event Case Reports are evaluated, investigated and accurately computerised
Note = For Contract positions functionality may be narrowly defined based on business needs
AE CASE MANAGEMENT
Receipt
Execute receipt of Drug Safety phone calls and complete telephone AE form
Create phone call communication logs in ARISg
Triage
Support the triage of cases conducted by Senior Specialist as needed
Assessment
Execute QC on key fields of serious cases
Create key fields updates in ARISg based on QC, as needed
Execute case assessment (review events, determine labeledness, identify co-manifestations, review coding, determine causality)
Create narratives as needed
Review & update auto-narrative as needed
Create draft company comments for serious cases
Develop event rankings
Create dechallenge / rechallenge determinations
Develop follow-up needs for AE reports
Create targeted follow-up letters
Review and update generated follow-up letters as appropriate
Authorize (approve) non-serious cases
Create major modifications following Medical Review
Medical Review
Support the identification of corrections and creation of updates in ARISg following medical review
PHARMACOVIGILANCE (APPROVED PRODUCTS)
PSURs
Update AE reports within safety database to support line listings
COMPLIANCE, STANDARDS, TRAINING & PROJECT MANAGEMENT
Preparation for Regulatory Inspection
Support the evaluation of current processes and assess alignment with regulatory expectations, guidelines, mandates
INTERNAL GLOBALSAFETY DEPARTMENT DEVELOPMENT
Participate in team meetings within the drug safety department
Contribute to the orientation and training of staff as needed.
The candidate must be able to produce a high volume of high quality cases within a busy Drug Safety work environment. Healthcare professionals are preferred.
Trial Safety Manager
Manager, Trials Safety Surveillance
Purpose
To provide excellent safety support to Development and Marketed product studies
To assist medical affairs teams and the lead safety MD in identifying and managing safety concerns for products
To ensure effective safety surveillance across trials
To draft safety sections of key trial documents
Context and Responsibilities
The Manager, Trials Safety Surveillance:
A global role, based in Warren, NJ
Reports (at a minimum) to:
Assoc Director, Trials Safety Surveillance
Responsible for:
Identifying and assisting in the management of safety concerns within trials
Assisting Medical Affairs trials teams in implementing, executing and concluding trials
Assisting lead safety MDs in their evaluation of products’ safety profiles
Maintaining knowledge of safety profiles for treatments in a specific trial area.
Key Activities
Governance
Product Development Committee
Support the review of PDC Materials
Support the Lead Safety MD in development of safety data presentation
Support the generation of contextual analysis & background data for PDC topics
Study Review Committee Representation
Contribute to the review of SRC Materials
Support Lead Safety MD review of SRC materials
Participate in SRC Meetings as required
Company Safety Committee (CSC)
Create materials for CSC review as required
Internal DMCs
Create & supply materials to DMCs as required
Create DMC Charters, participate in DMC meetings & document conclusions
Execute DMC recommendations
Membership of internal DMCs
Product Labelling
Core Data Sheet Creation & Maintenance
Contribute to the synthesis of key safety recommendations and signals for inclusion in data sheet
Contribute to the initial version to safety sections of Core Data Sheet
Contribute to core data sheet development
Participate in CDS review meetings
Review core data sheet
Create draft updates to the core label as required
Package Insert / Labeling Updates
Create draft updated safety content based on Core & Safety analyses
Support the creation of labeling prose text updates, based on internal analysis
Issues management
Issues Management
Contribute to issues elevation & initial Internal notification
Execute the determination of issue nature
Execute follow up internal notification
Execute issue management plan
Facilitate continuing issue evaluation, refining plan as necessary
Review issue data and close on recommendations
Create issue response document
Support communication planning
Crisis Management
Support the formulation of a rapid response system and corporate policy / procedure to address safety crises
Execute the triage of potential issues to safety committee
Create contextual analysis with supporting epidemiologic analyses for background
Contribute to the execution of a Crisis Management response plan
Contribute to ongoing review issue and crisis management plan
Regulatory Enquiries
Contribute to regulatory inquiry review
Review relevant data and draft response incorporating latest findings from ongoing pharmacovigilance and epidemiological analysis
Safety Enquiries (Internal & External HCP & consumer)
Support the intake & evaluation of enquiries
Contribute to the strategy for response & undertake response drafing
AE CASE MANAGEMENT
Triage
Contribute to report escalation as required
Conventions Maintenance
Support the establishment & updating of conventions/templates
Commercialization support and liaison to other functions
Commercial Support
Support training to employees on product safety profiles/issues
Review publications, including abstracts, manuscripts, and speaker presentations
CRO Selection
Participate in reviews of Contract Research Organisation capabilities and performance
Support the evaluation of CRO performance
Support the development of safety outsourcing strategies
CRO Contracts
Facilitate adherance of outsourced studies to dept standards
Support QA of CRO safety data & oversight of CRO’s safety performance
Trial Safety Support
Product Specific Support
EOP2 Package & Pre NDA meeting support
Support review of safety data and QC
Informed Consent (Core content)
Contribute to the Safety risk section of IC
EU CTD Annual Report
Contribute to the development of the EU ASR
Draft & QC clinical trial safety sections
IND Annual Report
Create tables of aggregate and reconciled SAE’s across Clinical and Safety databases
Draft prose for Safety section of annual report, based on template
Product Safety Surveillance Plan
Contribute to surveillance plans for products in pre-market clinical trials for generation of hypotheses to investigate
Risk Management Plan development
Contribute to RMP content determination
Coordinate RMP development & contribute to RMP development
Draft risk management plan
Investigator Brochure
Create Safety section of IB based on Regulatory guidance
Review other IB sections generated by other inputs (clinical, regulatory, etc.)
Provide supporting Safety data for context to other sections as needed
IRB Updates / Responses
Support responses to specific inquiries; Formulate and communicate Institution or Centralized IRB requests
Support ongoing updates of data and findings for IRB’s
Investigator enquiries
Contribute to the resolution of ad hoc queries, developing strategy for response
Support review of safety data in preparation for response, draft & QC response
Individual Study Planning
Clinical Protocol And Safety Endpoints Definition
Contribute to the provision of safety data on the compound of interest
Support review & advice on Safety Endpoints, data to capture during trial, process, key review activities and timing
Review and provide input
Statistical Analysis Plan
Create expectations of expected, anticipated statistical analyses to run over trial
Create recommendations for data management plan incorporation
Review and provide input to the SAP
Provide product program wide input on safety statistical elements required for analysis
Ensure all appropriate safety tables, listings, graphs are included in SAP
Clinical Data Management Plan
Support determination of data required for capture during clinical trials
Develop Safety section of data management plan
Review and update data management plan based on updates to integrated safety viewpoint during trial
Case Report Form Development
Support determination of data required for capture during clinical trials
Contribute to review of final form for consistency across trials
Facilitate changes to Safety data capture process to reflect changes to CRF
Review and provide input to CRFs ensuring appropriate protocol CRF elements are incorporated
Safety Management Plan Development (Logistics, data flow focussed)
Develop study specific safety management plan, obtain team approval and execute
Coding Conventions Creation And Review
Contribute to coding conventions required across Safety and Clinical databases
Execute Coding Conventions within database, and roll out to interfaces
Provide ongoing assessment of success of conventions, perform review and update during reconciliation process
Investigator Meetings
Deliver presentation of SAE form completion, safety reporting and monitoring
Study Conduct
Protocol updates
Develop updates to protocol and protocol template in line with regulatory agency requirements (CFR & EU CTD)
Informed Consent Updates
Develop updated Inf Cons mid study as necessary; assess need to reconsent subjects in ongoing trials and initiate process
SAE Reconciliation
Execute the reconciliation of SAEs between Clinical and Safety databases
Clinical Line Listing Analysis and Reporting
Review AE’s & SAE’s on line listings (generated periodically by Clinical Operations)
Periodic Safety Database Locking
Execute finalization of entries and determine cut-off point; perform database lock
Distribute and communicate locked cut to CDM, clinical ops to support reconciliation
Developmental Product Safety Monitoring & Surveillance (Protocol specific)
Execute analysis of SAE’s by system for specific protocol
Review aggregated Safety/Clinical database for AE’s and SAE’s matching hypotheses
Protocol specific analysis of aggregate CTDB (frequency tables, shift tables, listings)
Developmental Product Safety Monitoring & Surveillance (Product wide)
Execute analysis of SAE’s by system, compound, and TA to detect significant correlation/causation
Support review of Safety/Clinical databases for AE’s and SAE’s matching hypothesis
Create summary reports for inclusion into clinical, filing, and post-marketing reports
Study Safety Data Review and Interpretation
Clinical Study Report
Receive preliminary study safety analyses from biostats
Review analyses for completeness and further analysis needs
Request additional tables as required
Contribute to the review and interpretation of study safety data
Compile aggregate SAE frequency tables for Clinical Study Report
Develop clinical study report narratives
Develop draft interpretation based safety sections of reports
Integrated Summary Of Safety
Support generation of ISS strategy and plan, gain team approval
Support the synthesise of key safety recommendations and signals for inclusion in ISS
Request and receive ISS tables from biostatistics
Review and generate prose for Safety sections of each trial’s outputs, as well as synthesized summary across all trials
120 Day Update
Develop strategy and plan
Review and aggregate SAE narratives
Review update data and provide interpretation
Review and comment on draft update
Compliance, Standards, Training & Project Management