Further information
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Summary
Three rotations within the Global Clinical R&D Operations Department as Clinical Trial Analyst (Operational Performance Management) , Medical Writer (Scientific & Medical Writing) and Clinical Study Manager (Global Study Management).
Responsibilities will include, but are not limited to, the following:
Clinical Trial Analyst:
• Supports development of feasibility criteria for clinical programs/studies, timeline projection and study specific recruitment and retention strategies
• Identifies, collects, integrates and analyzes internal and external data sets that may better enable the projection of program/study milestones, identification of potential countries and sites, and facilitate subject recruitment and retention strategies and tactics
• Identifies incidence and prevalence of targeted patient population, inclusive of identifying global vs. regional/local standards of care that must be considered
• Participates in early identification of potential risks to objectives above and contributes to the development of risk specific contingency plans to promote proactive remediation
• Conducts operational analysis and planning to ensure that subject recruitment strategies and tactics identified for a program/study are practical, experienced based a nd cost effective to execute, inclusive of identification, evaluation, selection and oversight of recruitment vendors
• Provides project management for the implementation of subject recruitment and retention strategies related to recruitment and media vendors including timelines and budget
• Participates in root cause analysis and makes adjustments to retention/recruitment planning.
• Supports identification, assessments of innovative techniques and tools that enable a data driven country/site selection and subject recruitment/retention processes
• Participates in retrospective analysis of issues to determine what happened, how many, how often, where the problem is, and what actions are needed within Clinical Research and Development Operations functions and other cross-functional areas
Medical Writer:
• Under direction and in collaboration with other relevant line functions, prepare Clinical Study Reports (CSRs) (CTD Module 5), and update of Investigator Brochures (IB).
• Schedule and chair kick-off meetings to discuss the procedure, content, roles and responsibilities for preparing the CSR and appendices (or IB update), develop timelines for the CSR and the appendices (or IB update), generate a comprehensive shell CSR – including dummy results sections - in advance of database lock to expedite timelines, create first draft (data-dependent sections), final draft and final version CSRs and circulate for review by the study team, arrange and conduct resolution meetings (if necessary) to discuss and resolve team review comments, send final version CSR (unapproved) for QC review, update it, and then send it to cQA for audit. Address audit findings and finalize CSR.
• Under direction, contribute to part of other documents such as Integrated Summaries of Efficacy and Safety (CTD Module 5 for FDA), Clinical Summaries of Efficacy (CTD Section 2.7.3) and Safety (CTD Section 2.7.4), Clinical Overview (CTD Section 2.5), Pediatric Investigation Plan, Requests of Product Specific Waiver and Confirmation of the Applicability of Class Waiver, applications for Orphan Drug Designations, and the clinical parts of briefing books.
• Participate in study and clinical team meetings with guidance of senior medical writers and assist the teams in resolving issues related to document preparation.
• Review data to determine the appropriate tabular and textual formats, and the clarity, logic and order of presentation.
Clinical Study Manager:
Provide support to functional study team to deliver clinical research studies on time, within budget and with good quality.
• Study Team – Provide support to cross-functional study team, develop, manage and maintain study timelines, minutes, budget and tracking, develop training materials and train team on study procedures, develop study management plan - study specific working practices, develop, manage, and maintain relationships with affiliate offices, develop study execution plans, provide mentoring and training
• Study Planning - Review and comment on synopsis and protocol and CRFs, develop overall study budgets, approve number of investigative sites, train study team in protocol, develop investigational product supply forecasting / management, input on project specifications and feedback on requirements for CTMS, guide structure and oversee set up TMF
• Selection and Evaluation of Investigative Sites - Participate in country selection, in collaboration with physician and CRS identify prospective investigative sites, review feasibility, participate in final investigative sites selection, develop and monitor investigative site budgets and negotiate financial terms of individual site budgets, manage site payments, monitor GCP/ICH site level compliance
• Identification and Selection of Vendors - Participate in preparation of RFP, assumptions and SOW, recommend vendors, contribute and review specs for vendors (IVRS, Labs), manage study vendors, review and approve vendor invoices
• Preparation of Study Documentation - Review essential regulatory documents, prepare detailed study timeline, develop and oversee risk management plan (e.g. for poor enrollment), prepare, review and approve Monitoring Plan, assure adherence to Monitoring Plan, review CRF design (paper), review eCRF specs (EDC) and review of CRF completion guidelines, design, review and approve study tools (for investigative site use), create study team contact roles and responsibilities, review DM documents (CRO and in-house studies), facilitate Development and Review of Data Review Plan
• Input Clinical Database, Safety and CSR Reports - Review edit specifications (paper and EDC), participate in creation of user management tool (UMT), execute EDC User Acceptance Testing (UAT) scripts, review Summary Reports, CSR review – appendices and approval, oversight of IND safety report distribution to investigators and study team
• Initiation and Site Start Up - Prepare and review material for investigator meeting and CRA Training, conduct CRA training, plan / organize / conduct Investigator meeting, oversight of country regulatory approvals (e.g. CTA, MoH), obtain country / site IRB / ethics committee approval, address issues from IRB discussion, prepare / review regulatory package (essential documents - blank forms and templates for 1572s, financial disclosure, etc.), prepare study binder for investigator meeting, obtain appropriate country/site insurance, authorize investigational product shipment to investigational sites, including (in association with Regulatory) the initial shipment, review and approve site-specific informed consent forms
• Enrollment and Maintenance of Subjects- Ensure enrollment is tracked and recorded appropriately, compile enrollment status, update recruitment strategy, address enrollment and retention issues, verify milestones for investigative site payments
• Follow-Up of Site and Subjects - Oversight of clinical monitoring to ensure quality data (in-sourced or out-sourced), review and approve monitoring trip reports, resolve issues with clinical team from patient medical management, review data as needed, schedule and conduct CRA meetings / teleconferences, identify that additional CRFs/eCRFs are required, review additional CRFs/eCRF specs, follow up on outstanding queries, review CRFs, follows up on outstanding CRFs and DCFs, perform ongoing resolution of subject eligibility, resolve study conduct issues, address site issues found during audits, support DMC reviews, ensure TMF is current
• Close Out - Coordinate study close out, case book review, reconcile payments, reconcile study budget, complete all archiving, reconcile TMF
Skills/Knowledge Required:
• B.A. degree in Science, Mathematics or a related discipline.
• Coursework or interest in pharmaceutical industry, specifically the clinical research.
• Excellent communication and excellent organizational skills
• Ability to multi-task effectively and prioritize assignments from multiple sources
• Basic knowledge of clinical research budgets including processing and tracking of site and vendor payments
• Basic understanding of project management desired
• Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, PowerPoint
• Knowledge of drug development process
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
Qualifications
B.A. degree in Science, Mathematics or a related discipline.
Req ID: 14000134
Primary Location: United States-New Jersey-Summit
Job: Corporate Affairs
Organization: Celgene Corporation
Schedule: Regular
Shift: Standard
Employee Status: Individual Contributor
Job Type: Full-time
Job Level: Day Job
Travel: No
Job Posting: 2014-01-24 00:00:00.0
Summary
Three rotations within the Global Clinical R&D Operations Department as Clinical Trial Analyst (Operational Performance Management) , Medical Writer (Scientific & Medical Writing) and Clinical Study Manager (Global Study Management).
Responsibilities will include, but are not limited to, the following:
Clinical Trial Analyst:
• Supports development of feasibility criteria for clinical programs/studies, timeline projection and study specific recruitment and retention strategies
• Identifies, collects, integrates and analyzes internal and external data sets that may better enable the projection of program/study milestones, identification of potential countries and sites, and facilitate subject recruitment and retention strategies and tactics
• Identifies incidence and prevalence of targeted patient population, inclusive of identifying global vs. regional/local standards of care that must be considered
• Participates in early identification of potential risks to objectives above and contributes to the development of risk specific contingency plans to promote proactive remediation
• Conducts operational analysis and planning to ensure that subject recruitment strategies and tactics identified for a program/study are practical, experienced based a nd cost effective to execute, inclusive of identification, evaluation, selection and oversight of recruitment vendors
• Provides project management for the implementation of subject recruitment and retention strategies related to recruitment and media vendors including timelines and budget
• Participates in root cause analysis and makes adjustments to retention/recruitment planning.
• Supports identification, assessments of innovative techniques and tools that enable a data driven country/site selection and subject recruitment/retention processes
• Participates in retrospective analysis of issues to determine what happened, how many, how often, where the problem is, and what actions are needed within Clinical Research and Development Operations functions and other cross-functional areas
Medical Writer:
• Under direction and in collaboration with other relevant line functions, prepare Clinical Study Reports (CSRs) (CTD Module 5), and update of Investigator Brochures (IB).
• Schedule and chair kick-off meetings to discuss the procedure, content, roles and responsibilities for preparing the CSR and appendices (or IB update), develop timelines for the CSR and the appendices (or IB update), generate a comprehensive shell CSR – including dummy results sections - in advance of database lock to expedite timelines, create first draft (data-dependent sections), final draft and final version CSRs and circulate for review by the study team, arrange and conduct resolution meetings (if necessary) to discuss and resolve team review comments, send final version CSR (unapproved) for QC review, update it, and then send it to cQA for audit. Address audit findings and finalize CSR.
• Under direction, contribute to part of other documents such as Integrated Summaries of Efficacy and Safety (CTD Module 5 for FDA), Clinical Summaries of Efficacy (CTD Section 2.7.3) and Safety (CTD Section 2.7.4), Clinical Overview (CTD Section 2.5), Pediatric Investigation Plan, Requests of Product Specific Waiver and Confirmation of the Applicability of Class Waiver, applications for Orphan Drug Designations, and the clinical parts of briefing books.
• Participate in study and clinical team meetings with guidance of senior medical writers and assist the teams in resolving issues related to document preparation.
• Review data to determine the appropriate tabular and textual formats, and the clarity, logic and order of presentation.
Clinical Study Manager:
Provide support to functional study team to deliver clinical research studies on time, within budget and with good quality.
• Study Team – Provide support to cross-functional study team, develop, manage and maintain study timelines, minutes, budget and tracking, develop training materials and train team on study procedures, develop study management plan - study specific working practices, develop, manage, and maintain relationships with affiliate offices, develop study execution plans, provide mentoring and training
• Study Planning - Review and comment on synopsis and protocol and CRFs, develop overall study budgets, approve number of investigative sites, train study team in protocol, develop investigational product supply forecasting / management, input on project specifications and feedback on requirements for CTMS, guide structure and oversee set up TMF
• Selection and Evaluation of Investigative Sites - Participate in country selection, in collaboration with physician and CRS identify prospective investigative sites, review feasibility, participate in final investigative sites selection, develop and monitor investigative site budgets and negotiate financial terms of individual site budgets, manage site payments, monitor GCP/ICH site level compliance
• Identification and Selection of Vendors - Participate in preparation of RFP, assumptions and SOW, recommend vendors, contribute and review specs for vendors (IVRS, Labs), manage study vendors, review and approve vendor invoices
• Preparation of Study Documentation - Review essential regulatory documents, prepare detailed study timeline, develop and oversee risk management plan (e.g. for poor enrollment), prepare, review and approve Monitoring Plan, assure adherence to Monitoring Plan, review CRF design (paper), review eCRF specs (EDC) and review of CRF completion guidelines, design, review and approve study tools (for investigative site use), create study team contact roles and responsibilities, review DM documents (CRO and in-house studies), facilitate Development and Review of Data Review Plan
• Input Clinical Database, Safety and CSR Reports - Review edit specifications (paper and EDC), participate in creation of user management tool (UMT), execute EDC User Acceptance Testing (UAT) scripts, review Summary Reports, CSR review – appendices and approval, oversight of IND safety report distribution to investigators and study team
• Initiation and Site Start Up - Prepare and review material for investigator meeting and CRA Training, conduct CRA training, plan / organize / conduct Investigator meeting, oversight of country regulatory approvals (e.g. CTA, MoH), obtain country / site IRB / ethics committee approval, address issues from IRB discussion, prepare / review regulatory package (essential documents - blank forms and templates for 1572s, financial disclosure, etc.), prepare study binder for investigator meeting, obtain appropriate country/site insurance, authorize investigational product shipment to investigational sites, including (in association with Regulatory) the initial shipment, review and approve site-specific informed consent forms
• Enrollment and Maintenance of Subjects- Ensure enrollment is tracked and recorded appropriately, compile enrollment status, update recruitment strategy, address enrollment and retention issues, verify milestones for investigative site payments
• Follow-Up of Site and Subjects - Oversight of clinical monitoring to ensure quality data (in-sourced or out-sourced), review and approve monitoring trip reports, resolve issues with clinical team from patient medical management, review data as needed, schedule and conduct CRA meetings / teleconferences, identify that additional CRFs/eCRFs are required, review additional CRFs/eCRF specs, follow up on outstanding queries, review CRFs, follows up on outstanding CRFs and DCFs, perform ongoing resolution of subject eligibility, resolve study conduct issues, address site issues found during audits, support DMC reviews, ensure TMF is current
• Close Out - Coordinate study close out, case book review, reconcile payments, reconcile study budget, complete all archiving, reconcile TMF
Skills/Knowledge Required:
• B.A. degree in Science, Mathematics or a related discipline.
• Coursework or interest in pharmaceutical industry, specifically the clinical research.
• Excellent communication and excellent organizational skills
• Ability to multi-task effectively and prioritize assignments from multiple sources
• Basic knowledge of clinical research budgets including processing and tracking of site and vendor payments
• Basic understanding of project management desired
• Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, PowerPoint
• Knowledge of drug development process
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
Qualifications
B.A. degree in Science, Mathematics or a related discipline.
Req ID: 14000134
Primary Location: United States-New Jersey-Summit
Job: Corporate Affairs
Organization: Celgene Corporation
Schedule: Regular
Shift: Standard
Employee Status: Individual Contributor
Job Type: Full-time
Job Level: Day Job
Travel: No
Job Posting: 2014-01-24 00:00:00.0
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