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Job Details

Senior Clinical Monitoring Associate (m/f) Freiburg

Company: inVentiv Health Clinical
Location: Freiburg im Breisgau (79098)
Reference: AS CMA
Closing Date: 01 Nov 16
Type: Permanent
Salary (£): Negotiable

Job Summary:

inVentiv Health Clinical are currently recruiting for a dedicated and motivated Senior Clinical Monitoring Associate with previous clinical research experience in Freiburg to support the CRA team of one of his sponsor clients.



* Excellent communication (verbal and written) interpersonal and organizational skills with demonstrated attention to detail
* Ability to recognize confidential information and maintain strict confidentiality of restricted information
* Ability to efficiently organize and prioritize work within a multifaceted framework
* Ability to maintain excellent working relationship with a broad range of trial staff
* Sense of urgency and display “can do attitude”
* Continuously seeks improvement in self and of processes
* Strong time management skills in order to meet deadlines



Support the Country Clinical Monitoring Team (CCMT) in all clinical trial related aspects to ensure timely conduct of clinical trials. Facilitate information flow between all members of the CCMT, in-house teams and site personnel as appropriate.

Main Responsibilities:

Provide general administrative support including, but not limited to:

* Support travel and expense management for the CCMT, if required
* Provide external and internal communication support: Email, fax and phone
* Organize internal and external meetings, telephone conferences, etc., and draft minutes
* If required, manage local files as applicable, e.g., maintenance of the local regulatory files as required by the local regulatory requirements and Standard Operating Procedures (SOPs), resource training files
* Act as the contact person for CLINICAL RESEARCH ASSOCIATES (CRAs) in case of absence/travel
* Assist the CCMT as needed to support assigned projects

Provide general study support including, but not limited to:

* Support CCMT in the clinical study set-up for administrative and logistical tasks
* Track invoice and follow up on payments to investigator sites if required
* Organize shipment of documents to CRAs, FSP/ASP Start-up Team, investigator sites and Headquarters(HQ) according to CCMT requests
* Transmit, collate, track, and file documents and data for the CRA/CCMT and provide alerts regarding missing information
* Communicate and work with local study coordinator and/or regulatory coordinator to ensure timely completion of all required documents for submission to IRB/REB or other local committees, as needed and if applicable. For Central IRBs, work with the vendor to ensure timely submissions to completion and approvals. Track and follow submission progress to completion. Report to the CCMT as needed.
* Perform quality checks and upload documents to the electronic Trial Master File (eTMF)
* Regularly update and maintain information in ACTTrials, to ensure that accurate information is reflected
* Act as Super User of ACTTrials for a country / cluster of countries, if required
* Support CCMM, including but not limited to coordinate site teleconferences at the request of the CCMM if needed, especially during the site selection and feasibility phase
* In close collaboration with the CCMM extract reports from clinical systems (e.g., ACTTrials, ACT.CTP, eTMF, ACT.Plan)
* Upload contracts, including legacy contracts into the database (ConTRACKTs) if required
* Assist in identifying and implementing best practices and continuous improvement plans
* Prepare the Study Drug release, i.e., collect, quality check and prepare documents for Study Drug approval and release in collaboration with CRAs
* Any other duty as needed

Senior CMA:

As a senior CMA you will work closely with the CCMM and the CRAs by providing centralized support to the CCMM and CRAs, assisting with sponsor oversight, preparation, organization and follow up of investigator and study site selection, site communications and additional study-related activities to support the efforts of the regional team.

* Prepare investigator contracts (Exhibit B) incl. tracking contract status, cycle time if applicable
* Preparation of contract Amendments and Consultant agreements, if needed
* Review site payment status and follow up on discrepancies, if needed
* In close collaboration with the CRA/CCMM, review clinical study documents for accuracy and completeness, e.g., Food and Drug Administration Form FDA 1572s, curriculum vitae (CVs), IEC/IRB questionnaires, approvals and renewals, IEC/IRB membership list, contracts
* Regularly review study document (e.g. TMF/e-TMF checklists) and pro-actively follow up on missing documentation
* Support CCMM/CRA in study oversight: Follow up on issues mentioned in the weekly study update with CCMT (e.g., reminder to CRAs, CCMMs) and send regular reminders, if required; support in keeping timelines by tracking the tasks per project
* Support CCMM/CRA in site identification and site selection process
* Support CCMM/CRA with resolution of investigational site queries
* Perform ACTtrials checks for completeness and accuracy of the system/milestones on a regular basis
* Liaise with project team members regarding study site issues, support of CRA in follow up of closure of issues, if needed
* Support CRA on site if applicable

Apply for this job: Senior Clinical Monitoring Associate (m/f) Freiburg

Contact Information:

Address:  Main Office
Thames House, 17-19 Marlow Road Maidenhead, Berkshire
Reasons to work for inVentiv Health Clinical
Tel:  +44 (0) 1628 408 408
Website:  Visit Our Web Site

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