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.

Manager, Quality Assurance

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

Ergomed is recruiting Quality Assurance Manager with experience of managing Quality in clinical studies in the CRO environment. Duties and responsibilities of Quality Assurance Manager:

As QA Manager will be responsible for performing domestic and international audits that ensure compliance with the EMA and other worldwide health authority GCP regulations and guidelines, company SOPs, protocols, and industry standards, as applicable. This individual provides recommendations for corrective and preventative action to the Quality / Company Management team and tracks commitments until closure.

Essential Duties and Responsibilities include the following:

• Plans and conducts document, internal and external GCP audits of clinical research activities to assess compliance with EMA, ICH GCP, and local regulations, as well as with protocol and company SOPs. Depending on auditor’s expertize, routine reviews may include, but are not limited to TMF audits, investigational site audits, company systems audits (project management / monitoring, regulatory affairs, medical writing, clinical safety, data management and biostatistics), and vendor assessment audits (local CROs, wholesalers, archiving company, central laboratory, phase I units).

• Prepares clear and concise written reports of audit observations, including an assessment of compliance. Provides audit related metrics to Senior Management. Evaluates corrective and preventative action responses to audit findings for adequacy and timeliness and manages the closeout of all corrective and preventative actions.

• Provides support during preparations and hosting audits /inspections conducted by Sponsor companies / health authorities, as applicable.

• Assists with development of audit plans.
• Applies departmental SOPs and participates in the development of departmental SOPs.

• Assists with GCP internal training internally and where required external of investigators and service providers.

• Supporting Company staff by providing information and expert guidance on regulations and procedures related to GxP and Quality.

• Ensures compliance with all of Company policies and applicable industry standards. Works with the Head of Quality to assure alignment and compliance with Company’s Quality Management System, supports assessment of compliance and defines metrics to determine performance objectives.

Education and/or Experience:

• Bachelor’s degree in life sciences or related field required.

• Master’s degree in life sciences or related field preferred.

• Minimum of 7 years progressive experience in the regulatory compliance environment.

• Minimum of 5 years Quality auditing experience in the Pharmaceutical or CRO industries required.

Qualifications:

• Strong knowledge of GCPs, EMA regulations and ICH guidelines required.

• Knowledge of FDA and other Health Authority requirements desired.

• Able to interpret and apply GCP regulations and guidances, including 21CFR part 11 requirements.

• Maintains professional expertise and knowledge of local and international regulations related to Quality and GCP.

Computer Skills:

• Must be proficient in MS Office Suite.

• Strong knowledge of and ability to navigate Health Authority Websites (e.g. FDA, EMA, ICH).

• Prior hands-on experience with data management and validation process preferred.

Other Skills and Abilities:

• Excellent written and oral communication and presentation skills.

• Ability to prioritize and multi-task successfully in a fast paced environment.

• Excellent organizational skills and attention to detail are essential

• Ability to manage both day-to-day operations as well as project work.

• Ability to work both independently and in a collaborative team setting.

• Ability to effectively present information to management.

• Ability to interact effectively with all levels of associates both internally and externally, including investigators and study site personnel.

Position Demands:

This position requires travel; average travel for this position is 40% with some variation based upon the demands of the business imperatives. Travel is both domestic and international for the purpose of auditing GCP related activities.

Employment Type:

Full Time / Regular

Location:

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

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.

The Senior IT QA/CSV Associate

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

Responsibilities

• To assist IT Quality Manager in supporting the Quality processes, (Computerised Systems Validation, GXP, 21 CFR part 11 etc.) working within IT Quality Team on existing IT quality processes to ensure that the IT function delivers secure, robust and compliant systems and services.

• In support of the IT Quality manager the Senior IT QA/CSV Associate shall:

• Perform the reviews of existing processes and documentation. Identify gaps against requirements then author and implement for all processes and services.

• Under the guidance of the IT Quality Manager, Operate, Review and maintain Quality processes in support of Computerised Systems Validation and qualification such as;

   • Periodic Review

   • Change Control

   • Incident / Problem management

   • IT CAPA

• Perform risk assessments as required for IT infrastructure, applications and support processes, documenting and resolving any findings

• Produce Monthly quality service metrics report and present to Business Quality functions as required.

Line Management:

The Senior IT QA/CSV Associate IT will report to the Group IT Quality Manager.

Other Supportive Responsibilities:

• Work with fellow members of the IT team to ensure provision of a first class customer service & contribute to the development of the IT organisation to ensure it becomes the recognised champion of information provision.

• Work with IT colleagues and management team in support of IT projects.

• Work with appropriate external 3rd parties to ensure key suppliers work to our requirements, adding value to our business proposition as required

Essential Skills:

• Previous experience of working within Pharmaceutical / Medical services company

• Exposure to working with Quality management systems, specifically GxP and/or 21 CFR part 11.

• Exposure to or awareness of quality management process such as ISO9001 and ISO27001.

• Ability to coordinate complex tasks within the IT function and business as appropriate, including developing plans, coordinating resources, resolving issues and maintaining compliance to all relevant standards and methodologies.

• Good / Strong English language skills (written and spoken)

• Proven capability in writing documentation

• A good understanding IT Technologies

• Awareness/Certification in ITIL processes.

• Proven communication skills are essential in this role.

 

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

Clinical Trial Administrator

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

Job purpose:

CTA is personnel providing administrative support in a clinical study. A CTA is under supervision of project manager and clinical trial manager.

Duties and responsibilities

• Responsible for administrative support of clinical studies.

• Setting up of ERGOMED and Investigator site files, according to SOP’s provided either by the Sponsor, or by the ERGOMED.

• Assist with filing of the clinical study related documentation, according to the applicable Ergomed PM SOP or Sponsor SOP on Filing, with supervision of the Monitor and/or CTM/PM appointed.

• Any other task related to the specific clinical study performance, assigned by ERGOMED Management, either verbally or in writing.

Skills:

• Strong communicator.

• Fluent in English plus one or more European languages preferred.

• Ideally 1 years’ experience of working with essential documents in clinical trials in the pharmaceutical / CRO/ hospital environments.

• Strong analytical and numerate skills.

• Ability to multi task and organize work effectively.

• 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:

Guildford, Frankfurt, Krakow, Belgrade, Zagreb, San Antonio, Kiev, Sarajevo
Please send your CV and covering letter to: careers@ergomedgroup.com

Clinical Team Manager

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

Job purpose:

The Clinical Team Manager will be responsible for operational project management and will act as the direct project line manager to allocated study Monitors. CTM could be solely responsible only for NIS or studies which include only operational managements. The CTM proactively identifies, resolves/mitigates and escalates risks and/or issues to the PM/PD/HCO manager as necessary.

Duties and responsibilities

• Direct communication with project allocated Monitors, Site Managers and CTAs.

• Direct communication and collaboration with the Sponsor representative in projects where only operational management is contracted, i.e. if no ERG PM is assigned.

• Verifying and ensuring that project team members (Monitors, Site Managers, CTAs) are trained (e.g. GCP, SOP, indication, protocol, study specific procedures / requirements, etc. ) to perform their assignments.

• Organizing and facilitating Monitors’ Meetings throughout the project.

• Assisting PM in study financial administration.

• Organizing and facilitating project team meetings (e.g. weekly calls with Monitors, Site Managers, CTAs), and ensuring meeting minutes are reviewed, approved and distributed to all concerned parties.

• Developing, reviewing and revision of project documents (e.g. monitoring plan, CRF completion guidelines, study specific operating manual, study specific forms etc.).

• Supporting PM in development /developing (when no PM assigned) of study related ECIS share folder in order to facilitate sharing of key study documents / guidelines / templates, and reporting / review of study status reports and Key Performance Indicators (KPIs).

• Initiating corrective / preventative measures – e.g. update of study guidance documents, performing re-training, performing co-monitoring, etc.

• Investigator identification and selection, if this task is contracted to Ergomed
• Contracting investigational sites (e.g. investigator / team, institution as applicable).

• Supporting Regulatory Affairs group in regulatory and EC/IRB submission process.
• Reviewing and verifying that all required documents are in good order for the first Investigational Medicinal Product (drug) release to the investigational site.

• Supporting PM in setting up and maintenance of the clinical trial master files as per Ergomed /Sponsor SOPs and GCP (including TMF QC).

• Accountable for QC of Trial Master Files.

• Reviewing of Monitors’ reports.

• Reporting all site issues (unable to resolve on CTM level) to PM/designee with action plan / propositions for discussions.

• Reviewing and approval of site related invoices (e.g. patient travel expenses (if site management not contracted), investigator /institution invoices).

• Review of cumulative listings of study non-compliance issues and assess whether there are any trends at the site or on a study level and assess whether any additional corrective / preventative actions should be taken and communicate this responsible parties.

• Managing preparations for site specific audits, attending in-house project audits if required, analysis of received audit report, proposing and overseeing completion of Corrective and Preventative Action Plan.

• Study files reconciliation of the clinical part of the TMF (country and site files) towards the end of the trial before transfer to the Sponsor.

• Developing, reviewing, and revision of Ergomed SOPs within area of expertise in order to ensure consistency with Good Clinical Practices and other applicable regulatory standards / requirements.

• Participate in mentoring/training of new staff as well as performing co-monitoring visits, to assess junior staff performance.

Skills:

• Minimum 5 years’ experience as a CRA.

• Fluent English plus one other European language (German and French highly desirable).

• Strong analytical and numerate skills.

• International study project management experience.

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

• IT literate.

• 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

Site Manager

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

Job purpose:

Site Manager (SM) is engaged in facilitating clinical operations execution, of a particular clinical study, with aim to maximise utilisation of SSC resources. SM role is training, consultation, support and supervision of study site coordinators in particular study.  SM is under the supervision of RSML and Head of Site Management.

Duties and responsibilities

• Serving as the primary contact between Ergomed Site Management Group and the site staff/SSCs.

• Providing training, consultation, and support to Study Site Coordinators in a clinical study in collaboration with the Project team and RSML.

• Providing SSC training and support to assist the sites in making progress in a clinical study that is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH GCP, and the applicable regulatory requirement(s).

• Providing operational (“in house” and field) support to the project teams in planning and execution of a clinical study.

• Notifying Monitor /PM of any relevant site issue that is detected in contact with the site.

• Establishing and maintaining relationships with Study Site Coordinators, Investigators and Sub-Investigators to optimise performance in clinical studies.

• Reviewing Site Status Reports and SSCs’ Reports/Invoices.

• Assisting HSM, SSM and RSML in top line feasibility.

Skills:

• Fluent in German and English.

• Excellent organisation skills with attention to detail.

• Excellent interpersonal and communication skills.

Qualification:

BS or MS in Nursing or degree within life sciences 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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