Sr. Study Manager, Clinical Operations

Job Description
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.

- Completed BA / BS degree.
- 9+ years pharmaceutical industry related experience with a minimum of 6 years clinical study management experience plus 2 years direct global study management experience.

Leads cross functional study team to deliver clinical research studies on time, within budget and with good quality.

Responsibilities will include, but are not limited to, the following:

1. Study Team Leadership - Lead 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

2. 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.

3. 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

4. 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.

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 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. Close Out - Coordinate study close out, case book review, reconcile payments, reconcile study budget, complete all archiving, reconcile TMF.

Skills/Knowledge Required:

- Disease / therapeutic knowledge

- Excellent oral / written / presentation – communications skills

- Knowledge of GCP / ICH / FDA regulations and EU directive

- 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 (North America and global)

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 employee’s 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.

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Celgene Corp

Job Code

State or Province

New Jersey

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