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: 9-Nov-2016
Closing date: 31-Jul-2017

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: 9-Nov-2016
Closing date: 31-Jul-2017

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.

 

Software Developer

Date of posting: 9-Nov-2016
Closing date: 31-Jul-2017

Ergomed is recruiting a Software Developer with experience in software development in the CRO environment.

Essential Functions:

• Programming and further development of existing web applications and apps in Delphi®

• Development of html5 / JavaScript based frontend components in responsive web design (HTML5 / CSS3 / JavaScript / JQuery)

• Development of PHP based backend components

• Participation in deployment, maintenance and optimisation of our existing software and 2nd level support

• Close co-operation with designers, administrators and project leaders

• Technical design specification and documentation of software projects

• Testing of new programs to ensure that logic and syntax are correct, and that program results are accurate

Requirements:

• Successfully completed university degree in computer science or equivalent work experience

• Minimum of 2 years as a software developer required

• Proven experience in development of web applications in Delphi®

• Advanced knowledge of current web- and software development standards like HTML5, CSS3. XML, JavaScript / AJAX and versioning techniques with SVN

• Experience with relational database management systems, preferably InterBase and MySql

• Additional experience in other programming languages and database technologies, as well as knowledge of IT architectures and web server systems are advantageous

• Strong analytical and problem solving skills

• Execute assigned projects within established deadlines

• Must be able to work independently on projects and within a team environment

• Good German and English language skills (written and spoken), team-capable and resilient

Employment Type:

Full Time / Regular

Language Skills:

Fluent English – both written and spoken, German as second language preferred.

Location:

The successful candidates will ideally be located in our Germany, Cologne office or Croatia, Zagreb office.
Please send your CV and covering letter to: careers@ergomedgroup.com

The Senior IT QA/CSV Associate

Date of posting: 10-Feb-2017
Closing date: 31-Jul-2017

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.

 

IT Project Manager / Business Systems Analyst

Date of posting: 10-Feb-2017
Closing date: 31-Jul-2017

Responsibilities:

To be a key technical resource in the IT Business System Development function to deliver secure, robust and compliant systems and services.

Key functions and responsibilities:

• Perform business analysis as necessary to support project scope and quality objectives.

• Perform business analysis to document procedures and establish standards for use in the business and IT.

• Manage business systems projects as well as IT infrastructure projects.

• Performing stakeholder analysis for each project to ensure appropriate personnel involved.

• Determining resource requirement for the project; securing the resources in partnership with the functional heads and the approval from the Sponsor / IT Director to achieve project goals within budget

• Verifying and ensuring that project team members perform their assignments

• Organizing and facilitating project meetings throughout the project (initiation / kick off meeting, regular project team meetings during project execution, and project close-out meeting) – with project team members, other Ergomed functional groups as needed, vendors and Sponsor.

• Contributing to project documents as applicable based on knowledge and expertise.

• Developing/reviewing and revising project plans (e.g. project management plan, communication plan, recruitment plan, risk management plan, monitoring plan, safety management plan, data management plan, etc.) including specific Key Performance Indicators (KPIs) to ensure consistent and timely execution of the project with quality and within budget

• Management of project, including deliverables from all functional areas and vendors in accordance with project timelines, specifications, quality and regulatory practice.

• Reporting project status to Sponsor and Senior/Executive Management

• Responsible for project budget

• Preparing project budget forecast

• Negotiating out-of-scope tasks / costs with the Sponsor / IT Director

• Managing and tracking project expenditure

• In addition to project related tasks, both PM, considered as senior project staff, will be involved in development of Company processes and standard operational procedures by supporting the following activities:

• Development, review and revision of Ergomed procedures within their area of expertise to ensure compliance with good practice and other applicable regulatory standards/requirements

• Contributing to Ergomed training programs to improve staff’s competency and enhance internal knowledge about industry’s best practices, relevant guidance documents, Ergomed procedures.

• The IT Project Manager / Business Systems Analyst will report to the Group IT Business Systems Development Manager.

We expect:

• Proven project management skills and familiarity with project management methodologies (e.g., waterfall / V-model)

• Strong Business Analyst skills

• Good knowledge of IT infrastructure and system technologies

• Exposure to working with Quality management systems (knowledge of GxP / GAMP / 21 CFR Part 11 an advantage)

• 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

• Fluency in written and spoken English

• Proven capability in writing documentation

• Awareness/Certification in ITIL processes

• Proven communication skills are essential in this role

• Ability to communicate technical concepts to non-technical audience.

 We offer:

• Opportunity to work in a dynamic international healthcare company

• Future job development opportunities

• Competitive remuneration package

If you are interested in becoming a part of the Ergomed team, please send your CV and cover letter in English using application link. We look forward to hearing from you!

 

Clinical Project Manager

Date of posting: 06-Jul-2017
Closing date: 31-Jul-2017

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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