לוח משרות דרושים CRA למחקרים קליניים

Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.

Essential Functions

Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.

Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.

Assist with periodic review of study files for completeness.

Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information. Coordinate the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.

Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.

May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.

May collaborate with the clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions
Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
Collaborate and liaise with study team members for project execution support as appropriate.
If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

We have a vacancies for (Senior) Project Managers in our Neuroscience Team in the EMEA region.

Ideally we seek indication experience in the following areas for these roles (please note in your application your experience in any of the following):

Rare Disease: Myasthenia Gravis, Huntington's, ALS, DMD, CIDP, DM1 (myotonic dystrophy) and FSHD - CAR-T experience

Ophthalmology: General ophthalmology, Diabetic Macular Edema & Geographic Atrophy

Sleep, Epilepsy and psychiatry

Basket, Master Protocol or Adaptive Trial experience is an advantage


Discover Impactful Work:
Serves as the Project Lead and primary sponsor contact. Accountable for the overall delivery of the project (quality, time, cost) on behalf of the organization. Establishes and communicates customer expectations to the project team. Leads the cross functional project team to meet or exceed deliverables.

A day in the Life:

Is the primary contact between the sponsor and the organization at the project level.

Ensures escalation pathways adhered to internally and externally (Rules of Engagement - communication pathways).

On projects where the scope requires, ensures clear delineation in responsibilities and communication pathways for secondary project leads (such as lead in a specific region, lead for a specific vendor(s) or subset of delivery).

Ensures financial stewardship at a project level by demonstrating an intimate understanding of the contract, resource alignment to budget, management of Out of Scope activity, drive the Con Mod process/negotiations and team execution to timelines.

Establishes, communicates and manages the sponsor to achieve optimal delivery during the project

Drives Risk Identification and Issue Resolution at project level (RBQM/RESOLVE).

Ensures project team compliance with organization policies, SOPs, ICH- GCP, regulatory and project specific requirements.