21 days ago on jobs.celgene.com

Clinical Trial Study Manager (1 Year Contract to Start)

Celgene Switzerland SA

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Clinical Trial Study Manager (1 Year Contract to Start)

Clinical Trial Study Manager (1 Year Contract to Start)

Req #:16001764
Location:MARIN, CH
Job Category:Clinical Operations
Work Location:Marin, Switzerland Champs Montants 14A Marin 2074
Organization:Celgene R&D Sarl
Shift:Day Job
Employee Status:Limited Term
Job Type: Experienced
Job Level: Manager

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.


The Study Manager is responsible for

• 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, recommend number 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 meeting and 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)
8. Enrollment and Maintenance of Subjects - Ensure enrollment is tracked and recorded appropriately,
compile enrollment status, update recruitment strategy, address enrollment and retention issues
9. Follow-Up of Sites, Subjects and Data - Oversight of clinical monitoring to ensure quality data (inVersion
Date: 18-Mar-2011
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
10. Close Out - Coordinate study close out, coordinate case book preparation, reconcile payments, reconcile
study budget, complete all archiving, reconcile TMF
11. Line Management –May be responsible for overall performance management of direct reports,

• Oversee personnel and assure adherence to GCP/ ICH and SOPs/WPs
• Lead the performance review process for direct reports.
• Identify and address performance issues and training needs.
• Provide guidance regarding company policies and procedures.


Skills/Knowledge Required:

BA / BS Degree in relevant discipline
Minimum 4 years clinical study management experience with multinational experience
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