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Description
Job Title:
Study Manager
Job ID:
12800
Location:
Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary:
Regular
Category:
Clinical
Department:
Clinical Operations - 3603
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.
* Leading one or several cross functional study teams (and/or sub-teams) to deliver clinical research studies on time, within budget and with good quality in compliance with Regulatory Authorities regulations/guidelines and Celgene SOPs/WPs.
* Sharing best practices
* Contributing to process improvement initiatives
Responsibilities may include, but are not limited to, the following:
1. Study Team Leadership- Lead cross-functional study team and/or sub-team, develop, manage and maintain study timelines, minutes, budget and tracking, develop training materials and coordinate training on study procedures, develop study management plan - study specific working practices, develop, manage, and maintain relationships with affiliate offices, develop study execution plans
2. Study Planning - Review and comment on study documents such as synopsis, protocol, ICF and CRFs, develop overall study budgets, recommendnumber of investigative sites, oversee the development of investigational product supply forecasting and management, input on project specifications and feedback on requirements for CTMS, guide structure and oversee set up TMF
3. Selection and Evaluation of Investigative Sites - Participate in country selection, in collaboration with CRP and CRS, identify prospective investigative sites, review feasibility, participate in final investigative sites selection, develop and monitor investigative site budgets and oversee negotiation of financial terms of individual site budgets, manage site payments, monitor GCP/ICH site level compliance
4. Identification and Selection of Vendors - Participate in preparation of RFP, assumptions and SOW,recommend vendors, contribute and review specs for vendors (IVRS, Labs), management of vendor oversight, review and approve vendor invoices
5. 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 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
6. Input Clinical Database, Safety and CSR Reports - Review edit specifications (paper and EDC), execute EDC User Acceptance Testing (UAT) scripts, facilitate development and review of Clinical Data Review Plan, review Summary Reports, CSR review appendices and approval, oversight of safety report distribution to investigators, study team and ECs as applicable. Participate in SAE reconciliation
7. Initiation and Site Start Up - Prepare and review material for investigator meetingand CRA Training, conduct CRA training, plan / organize / conduct Investigator meeting, oversight of country regulatory approvals (e.g. CTA, MoH), oversee country / site IRB / EC approval, , oversee and/or prepare, review regulatory package (essential documents - blank forms and templates for 1572s, financial disclosure, etc.), review regulatory packages, develop and coordinate materials 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 informed consent forms (e.g. site or country specific ICFs)
1. Enrollment and Maintenance of Subjects - Ensure enrollment is tracked and recorded appropriately, compile enrollment status, update recruitment strategy, address enrollment and retention issues
2. Follow-Up of Sites, Subjects and Data- Oversight of clinical monitoring to ensure quality data (in-sourced or out-sourced), oversee review and approval of monitoring trip reports, review data as defined by Study Team, schedule and conduct CRA meetings / teleconferences, follow up on outstanding CRFs and DCFs, perform ongoing resolution of subject eligibility, oversee resolution of study conduct issues, address site issues found during audits, support DMC reviews, ensure TMF is current
3. Close Out - Coordinate study close out, coordinate case book preparation, reconcile payments, reconcile study budget, complete all archiving, reconcile TMF
4. Line Management May be responsible for overall performance management of direct reports, including:
8. Oversee personnel and assure adherence to GCP/ ICH and SOPs/WPs
9. Lead the performance review process for direct reports.
10. Identify and address performance issues and training needs.
11. Provide guidance regarding company policies and procedures.
Skills/Knowledge Required:
* Disease / therapeutic knowledge
* Excellent oral / written / presentation solid communications skills
* Knowledge of ICH/GCP and regulatory guidelines/directives
* Leadership skills (get it done) / negotiation skills
* Mentoring / coaching
* Time management - ability to effectively multi-task and prioritize
* Financial budgeting and forecasting skills
* Project management / organizational skills
* Solid computer skills requirement of MS applications including (but not limited to) MS Project, Word, Excel
* Study Tools including electronic system skills CTMS / EDC
* Knowledge of drug development process
* Cross functional and cross-cultural awareness
* Ability to work in a matrix environment
* Interpersonal skills
Key Competencies:
* Manages execution
* Commitment to quality
* Thinks strategically
* Uses sound judgment
* Drive for results
* Planning
* Fosters open communication
* Acts with integrity
* Fosters team work
* Analysis of issues
Recognizes global implications
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.
Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employees temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the at-will employment relationship between the employee and Celgene.
Details:
Job Id:
33989534
Posted / Updated:
3/2/2012 4:00:30 AM
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