International Clinical Trial Manager

INTERNATIONAL CLINICAL TRIAL MANAGER - BASEL - 100%

If you are a Clinical Trial Manager, then you are THE person we looking for!

This very exciting opportunity is a CONTRACTING POSITION planned to START THE 13TH OF MARCH 2017 until the 12TH OF MARCH 2018 for one of the BIGGEST PHARMACEUTICAL PLAYERS based in BASEL.

Key Activities/Responsabilites:

PROVIDES DIRECTION AND LEADERSHIP TO ONE OR MORE CLINICAL OPERATIONS TEAMS (DEPENDING ON COMPETENCY LEVEL ICTM MAY NOT HAVE LEADERSHIP RESPONSIBILITIES)

- Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management
- Builds effective and efficient high performing operations teams
- Creates team culture and promotes team spirit
- Develops and maintains effective working relationships

RESPONSIBLE AND/OR CONTRIBUTES TO THE DEVELOPMENT AND MANAGEMENT OF THE STUDY TIMELINES, RESOURCES, BUDGET, RISK AND QUALITY PLANS

- Responsible to identify and update operational tracking tools, including systems to meet the needs of the operations team and ensures reporting to the ICPL
- Develops and manages clinical study budgets. Communicates variances in the budget and action plan for resolution to the ICPL.

PROVIDES CLINICAL OPERATIONS EXPERTISE TO ENSURE OPERATIONAL FEASIBILITY AND DELIVERY

- Develops the site feasibility questionnaires and creates the study level patient recruitment plan and retention strategies
- Analyzes the feasibility data across countries
- Provides operational input and insight into all study related documentation and processes

OVERSEES FORECASTING OF CLINICAL/NON-CLINICAL SUPPLIES

- Designs drug assumption and supply chain process
- Oversees the forecasting and management of non-clinical supplies

DELIVERS THE OPERATIONAL ELEMENTS OF THE STUDY PLAN

- Chairs operations team meeting and organizes the investigator meetings, monitor training, CRO kick-off meetings
- Ensures that safety reporting is established and maintained for the duration of the study and that reporting timelines are met
- Proactively manages actual study level recruitment versus planned patient recruitment status and communicates variance to the ICPL and implements contingencies in consultation with the ICPL
- Primary contact with CRO and affiliates to maintain oversight of performance, issues, and their resolution and identify systematic issues and coordinates any corrective action

PROVIDES THE DAY-TO-DAY OPERATIONAL MANAGEMENT OF CROS AND VENDORS TO ENSURE DELIVERY AGAINST CONTRACTED SCOPE OF WORK

- Performs ongoing vendor management, including independent negotiation of scope of work, budgets, performance management, and issue resolution
- Develops and executes appropriate site and CRO/vendor audit and quality plans

IDENTIFIES AREAS OF BEST PRACTICE AND PROCESS IMPROVEMENTS

You bring for this role the following qualifications:

- Life sciences degree or nursing equivalent or substantial experience in a clinical research/a healthcare environment
- Proven clinical development experience of the operational aspects of all stages of clinical studies preferably working in a Global environment and/or including monitoring or leading affiliate teams, working with vendors and/or CROs, drug supply management and planning operational activities to achieve database lock
- Experience of project managing operational aspects of a clinical study including development of timelines, budgets and resource plans
- Proven ability to successfully achieve results within a multi-cultural and geographically diverse team
- Experience of working as part of a large team and leading small study or functional teams, with a proven ability to be an active member of the team and motivate and lead a small team to deliver against commitments
- Well developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization
- Good knowledge of ICH GCP
- knowledge Clinical Trial management within the therapeutic area is desirable
- Proficient computer skills across multiple applications
- Fluency in written and spoken English
- High ethical standards, Leadership Commitments, Project Management, Collaboration and Teamwork, Communication, Personal Organization, Cost and financial awareness and Decision Making

If you recognize yourself in this profile, so please don't hesitate to send me your CV I look forward to receive your application!

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