A leading pharmaceutical company are currently looking to hire a Senior Clinical Site Manager to work on a home-based capacity in Poland. This an exciting opportunity to join one of the top global pharmaceutical companies.
Job Responsibilities:
- Building relationships with investigators and site staff.
- Conducting, driving and managing country specific feasibility and/or site pre-qualification and qualification activities, which may include:
- Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
- Conducting remote Qualification Visits (QVs).
- Generating visits/contact reports, using judgment to identify site issues and problem solving to direct resolution.
- Developing a strategy to configure, distribute, and collect, and review and approve, high-quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.
- Customising, reviewing, and negotiating as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customising and negotiating any amendments.
- Preparing and submitting IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.
- Submitting all pertinent documentation to the trial master file as per project plans/sponsor/company policy.
- Forecasting, developing, managing, and revising plans and strategies for:
- IRB/IEC and MoH / RA submission/approval.
- Site activation.
- Patient recruitment & retention.
- Updating and maintainingappropriate Clinical Trial Management systems (CTMS) in a timely manner.
Act as the company's direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues.
- Building relationships with investigators and site staff.
- Facilitating and supporting site with access to relevant study systems and ensure sites are compliant with project specific training requirements.
- Evaluating if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.
- Addressing and resolving issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.
- Addressing/evaluating/resolving issues pending from the previous visit, if any.
- Following-up on and respond to appropriate site related questions.
Ensure timely and accurate completion of project goals and update of applicable trial management systems.
- Working with team members to meet project goals, provide a strategy for efficient project planning and goal completion, and encourage the support of team members where required.
- Updating all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS).
- Ensuring timely and high quality data entry compliance from sites, managing and submitting all relevant documents to the Trial Master File (TMF).
- Ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.
- Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.
- Maintaining a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, and modelling the high performance culture values.
Skills and Requirements:
- Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience.
- Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
- Strong interpersonal, verbal, and written communication skills.
- Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables.
- Effective time management in order to meet study needs, team objectives, and department goals.
- Ability to successfully work in a ('virtual') team environment.
- Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned.
- Holds a driver's license where required
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Reem Iskandarani at 0203 854 2629 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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