To perform day-to-day management of the project.
To act as main line of communication between the CRO and external parties involved for operational issues.
To ensure that the project is conducted and documented within the agreed timelines, budget, assigned resources, and quality standards.
To write a Project Plan.
To make the project’s planning of financials, resources and deliverables and to update those on monthly basis.
To identify investigators and service suppliers needed, if any, with adequate qualifications, resources and facilities to safely and properly conduct and document the trial.
To develop or arrange development of all relevant documents needed to conduct and report the project in line with contractual agreement(s), Project Plan, protocol, ICH GCP, SOPs, other relevant guidelines and legislation for project team members, investigators, service suppliers and third parties, if any.
To arrange written agreements with investigators and service suppliers, if any.
To arrange regulatory and ethics approvals.
To arrange the appropriate ordering and distribution of all trial supplies needed.
To provide leadership to the project team.
To make sure the performance of the Competence Center is in accordance with the Project Plan.
To track the agreed project milestones and take appropriate actions to safeguard milestones and budget.
To evaluate the study financials and progress with the Senior Project Leader as described in the Project Plan.
To report promptly on relevant project issues and at least on a monthly basis in writing on trial progress, budget expenditure, people resources, and significant findings/facts, deviations and deficiencies, conclusions, actions taken or to be taken and/or actions recommended to secure compliance to the Senior Project Leader.
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 |
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Geïnteresseerden kunnen hun c.v. ook rechtstreeks mailen naar andrea@pharmamediair.nl.
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