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Clinical Projectmanager (Interim)

Deze vacature staat offline!

De opdrachtgever

Farmaceut in de omgeving Utrecht

Omschrijving

To ensure that clinical projects are efficiently executed according to plan, the needs of the client objectives and in concordance with quality systems.

Responsibilities

Approximately 90% of the CPM's time is devoted to core Clinical Operations activities. These include:

Managing the Clinical Resource Organizations (CROs) servicing trials within a country, in conjunction with the Head of Country/Sub-Regional Clinical Operations (HCO).
Ensuring clinical trials are effectively executed from pre-study through close-out activities.
Ensuring trials are completed within budget, timeline, and enrollment commitments.
Co-monitoring sites to track progress.
Maintaining study budgets.
Ensuring all trials follow appropriate Standard Operating Procedures (SOPs).
Ensuring regulatory documentation is properly maintained before starting study.
Tracking drug and clinical trial supplies to ensure that sites have the materials required to conduct the study effectively.
Managing pre-selection and trial initiation activities.
Performing trial close-out activities.
Ensuring contracts are in place.

Tasks

To ensure the delivering of products or services to the client that meet the client’s expectations within the terms of the contract and the goals as set by the contract owner.
To supervise and control project management.
To evaluate project progress and financials with the Clinical Operations Manager.
To maintain the contractual relationship with the client and handling all contractual issues.
To report periodically progress and status of deliverables to the client as agreed in the contract.
To inform periodically the contract owner and/or the Deal Review Group about progress and status of deliverables, fulfillment of the contract terms and achievement of s goals.
To participate actively in the Deal Review Group to achieve the goals.
To ensure that the risks are (re-) identified and analyzed at each key decision point and risk management is performed.
To perform stakeholder management to influence decision-making around important decisions.
To negotiate with the client directly on matters related to fulfillment of the contractual obligations.
To monitor the occurrence of non-budgeted tasks (to be) performed by the project team and to take appropriate actions.
To control all changes to the contract.
To identify new opportunities to offer a new proposal to the client.
To approve the contracts with third parties.

De eisen

The recommended skills and qualifications for the CPM position include a B.S. degree or other relevant background, combined with three years of clinical trial monitoring experience and strong organizational skills.
Furthermore:

The ability to travel to sites is also a requirement. Clinical Trial Management and Execution Skills.
Business Process Skills.
Strong Global Clinical Practice and SOP knowledge.
Ability to ensure and manage compliance issues.
Resource Management Skills.
Advanced skills in manpower assessment requirements and management.
Strong Project Management Skills.
Excels in timeline development and management.
Advanced skills in budget management and tracking.
Excellent metrics management.
Vendor Management.
Manage the completion of all clinical trials with passion for continuous improvement.

Contactinformatie

Heb je interesse in deze vacature, meld je direct aan middels de button 'aanmelden' of neem contact op met:

Drs. Andrea Dorssers
Consultant Clinical
Biltstraat 443
3572 AW Utrecht
tel 030 231 7350
mobiel 06 22242929

Geïnteresseerden kunnen hun c.v. ook rechtstreeks mailen naar andrea@pharmamediair.nl.