ERGOMED

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Ergomed PLC does not accept unsolicited referrals or resumes from any source other than directly from candidates. We will not consider unsolicited referrals and/or resumes from vendors including and without limitation, search firms, staffing agencies, fee-based referral services and recruiting agencies. The submission of referrals or resumes by anyone other than a candidate directly to Ergomed PLC employees is strictly prohibited. Unsolicited referrals and resumes sent to Ergomed are deemed gratuitous, and the company will not be obligated or bound in any way to pay any referral or other fee if a person referred to us from a source other than a candidate is hired.

Notwithstanding the foregoing, resumes will be accepted from approved vendors who have written agreements in place with Ergomed PLC, and then only to the extent such agreement covers a specified position and, if required by such agreement, the submission of resumes by the vendor has been authorized in writing by Ergomed PLC for such specified position. Any resume submitted in the absence of a signed agreement will become the property of Ergomed and no fee shall be due.

Clinical Research Associate/ Monitor

Date of posting: 05-Oct-2017
Closing date: Ongoing

Ergomed is recruiting CRAs/Monitors with experience of managing clinical studies in the CRO environment.

Duties and responsibilities of CRA/Monitor

• To verify that the conduct of the study is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s).

• To verify that the rights and well-being of human subjects, clinical study’s participants, are protected.

• To verify that the investigator has adequate qualifications and resources, as well as that, facilities, including laboratories, equipment and staff are adequate for safely and properly conduct of the clinical study throughout the study period.

• To act as the main line of communication with Investigator and his team.

• To verify that the reported study data are accurate, complete and verifiable from source documents.

• To verify Investigational medicinal product and other study materials tracking.

• To report status of the projects to relevant Project Manager.

• Undertaking other study specific activities described in study/project operational plans/documents or timetables in line of his/her education and qualifications.

• To act as a mentor to the less experienced staff such as Clinical Trial Administrators and CRA/Monitors.

• To participate in the process of revision of relevant Standard Operating Procedures (SOPs).

• To perform presentations and training to the more junior staff (CTAs, CRA/Monitors) in line with their experience and as assessed by the Quality Management.

Qualifications:

• BS/Pharm.D/MSc/MD or RN, with 5 years of on-site clinical monitoring experience.

• Strong customer focus, ability to interact professionally within a client organization.

• Ability to prioritize multiple tasks and achieve project timelines.

• Sense of urgency in completing assigned tasks.

• Attention to detail.

• Excellent verbal and written communication skills.

• Must be computer literate and proficient in MS office.

• Ability to perform regionalized travel an average of 65%, depending on project needs.

Employment Type:

Full Time / Regular

Location:

The successful candidates will ideally be located in our USA, San Antonio office. Home base CRA will also be considered. Please send your CV and covering letter to: careers@ergomedgroup.com.

 

Clinical Project Manager

Date of posting: 05-Oct-2017
Closing date: Ongoing

Job purpose:

The Project Manager (PM) is the project main point of contact. responsible for training staff and managing the project to ensure that the project is executed according to the objectives defined by Sponsor, on time, within budget and as per quality standard of Ergomed and principles of Good Clinical Practice.

Duties and responsibilities

• Developing the study proposal and contributing to the BDMs.

• Resource Management, allocating clinical resources diligently.

• Verifying and ensuring that all assigned project team members are trained.

• Organizing and facilitating project meetings.

• Contributing to study documents development.

• Developing/review and revise project plans.

• Safeguarding quality of study conduct.

• Vendor selection.

• Investigator identification and selection.

• Contracting investigational sites.

• Supporting Regulatory Affairs group in the regulatory and EC/IRB submission process.

• Reviewing and verifying that all required documents are in good order for the first IMP release to the investigational site.

• Ensuring the set up and maintenance of the clinical trial master files.

• Responsible for project profitability

– Preparing study budget forecast

– Negotiating out-of-scope tasks

– Review of project grants / expense reports, and financial trackers

• Managing the preparations for study specific audits, attending in-house project audits, reviewing audit  reports, proposing and overseeing completion of Corrective and Preventative Action Plan.

Skills:

• Strong communicator.

• Strong analytical and numerate skills.

• Minimum 5 years’ experience as a project manager.

• International study project management experience.

• Ability to work effectively and deliver in a fast paced environment.

• Advanced Excel user.

• Confident to work both independently and within a team.

Qualification:

Life Sciences/ Scientific Degree preferred.

Location:

Zagreb, London, Guildford, Frankfurt, Kiev, Belgrade, Novi Sad, Krakow.
Please send your CV and covering letter to: careers@ergomedgroup.com

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