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international projects

Optimapharm is undergoing continuous and strong growth due to the increase in the number of projects in the countries where we operate. We are constantly looking for young talent, plus experienced and motivated experts who would like to join our team.

By joining our fast-growing team, you will have a great opportunity for further personal growth and career development. We offer the opportunity to work on international projects and to be a member of international clinical research teams. We offer good training opportunities, flexible working hours and a competitive compensation package.

If You are interested in pursuing your professional career at Optimapharm, please send Your CV in English to
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open job positions
Clinical Project Management Director (m/f) - Europe
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We are open to receive applications no matter your current location as the position can be based in any of Company’s offices in Europe.

The Clinical Project Management Director (CPMD) is responsible to lead, manage and support the Clinical Project Managers on assigned projects to ensure that OPTIMAPHARM delivers quality projects to its Clients within agreed project targets, time and budget, ensuring that expectations are fully met, including achievement of financial budgets for assigned projects.

The CPMD is responsible to promote new business by participating in preparation of proposals / project bids and attendance to the Client presentations/meetings (e.g. bid defense meetings) as appropriate and requested by Business Development Department (BDD) and/or senior management. The CPMD is responsible to provide expertise and consultation to BDD as requested during the proposal and bidding process.
The CPMD is an experienced leader with excellent project management and communication skills, responsible for liaising with senior management within the organization to continuously assess and improve operational project delivery.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education and/or Experience
  • University degree in medical or life sciences (or equivalent required).
  • Minimum of 8 years clinical research or other relevant experience required.
  • Minimum of 3 years of clinical project management experience.
  • Excellent knowledge of ICH GCP and ISO14155 Guidelines.
  • Excellent knowledge of relevant regulatory requirements.
  • Excellent interpersonal, written, oral and administrative skills.
  • Excellent team leadership skills
  • Ability to work in a fast-paced, team-oriented environment.
  • Computer proficiency is mandatory.
Language Skills

Ability to read, analyze, and interpret common scientific and technical journals. Fluent in local language and in English, both, written and verbal.

Communication and interpersonal Skills

Very good verbal and written communication skills. Very good interpersonal and negotiation skills. Ability to convey thoughts and findings in a clear, concise and accurate manner. Uses correct grammar, listens carefully and asks questions when necessary to ensure understanding. Maintain positive relationships with site personnel and colleagues. Demonstrates honesty and integrity in dealing with others. Works effectively with different types of people. Works effectively and efficiently in a matrix environment.

Mathematical Skills

Excellent numerical skills. Ability to compute rate, ratio, and percent and to draw and interpret graphs, charts, and tables of information. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Other Qualifications

Computer competency.
A current, valid driver’s license is required.
The position requires up to approximately 20% of travel.

By joining our fast growing and prosperous team, you will have a great opportunity for further personal growth and career development. We offer the opportunity to work on international projects and to be a member of international clinical research teams, a competitive salary, lots of training opportunities and flexible working hours.

Please send your CV in English and note that only shortlisted candidates that meet the requirements will be contacted for further selection process.

Regulatory Manager (m/f) - Europe
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We are open to receive applications no matter your current location as the position can be based in any of Company’s offices in Europe.

The Regulatory Manager (RM) is primarily responsible for the management and oversight of ethics and regulatory (including periodic and local safety submission) activities in accordance with applicable laws and regulations, applicable Company’s and/or Client’s/Sponsor’s Controlled Documents (CDs) [e.g. Standard Operating Procedures (SOPs), Work Instructions (WI), Supporting Documents (SD), Plans and Policies], current Good Clinical Practice (GCP), current ISO 14155 norm (if applicable) and current MEDDEV guidelines concerning clinical investigations.

The Regulatory Manager (RM) acts as a mentor and is responsible for line management of the assigned team members of the Regulatory Affairs Department. When applicable, RM is responsible to coordinate communication and collaboration between Regulatory Affairs Department, Client and other relevant OPTIMAPHARM’s Departments (e.g. Clinical Operations Department, Clinical Project Management Dept, Medical Affairs Dept. etc.) in order to ensure that deliverables and milestones on the assigned projects are met according to both, Company and Client requirements.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education and/or Experience
  • University degree in medical or life sciences (or equivalent required);
  • Minimum of 4 years clinical research experience required (preferably within both, pharmaceutical and CRO environment);
  • Minimum 3 years of experience with regulatory activities (Regulatory and Study Start-up Management, Regulatory and Ethics submissions management)
  • Excellent knowledge of GCP and ICH Guidelines required for clinical trial conduct, ISO 14155, MEDDEV guidelines concerning clinical investigations;
  • Excellent knowledge of regulatory requirements (international and local);
  • Excellent interpersonal, written, oral and administrative skills;
  • Ability to work in a fast-paced, team-oriented environment;
  • Excellent leadership and mentoring skills;
  • Proficient in cross-cultural communication
  • Prior experience working on clinical trials with ATMP and/or gene therapy will be considered a plus
  • Prior experience working on First in Man (FIM / FIH) trials, will be considered a plus
  • Prior experience in VHP will be considered a plus
  • Prior line management experience will be considered as advantage
Language Skills

Ability to read, analyze, and interpret common scientific and technical journals.

Mathematical Skills

Excellent numerical skills. Ability to compute rate, ratio, and percent and to draw and interpret graphs, charts, and tables of information.

Reasoning Ability

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Other Qualifications

Computer literacy.
A current, valid driver’s license is required.
The position requires up to 20% of travel.

By joining our fast growing and prosperous team, you will have a great opportunity for further personal growth and career development. We offer the opportunity to work on international projects and to be a member of international clinical research teams, a competitive salary, lots of training opportunities and flexible working hours.

Please send your CV in English and note that only shortlisted candidates that meet the requirements will be contacted for further selection process.

Senior Clinical Project Manager (m/f)
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Location: Any of Company’s offices in Europe

Responsibilities

The Senior Clinical Project Manager (SCPM) is a member of the international clinical development team that is primarily responsible for the setting up and management of a project according to the protocol and relevant project plans, current GCP ICH guidelines, applicable SOPs, relevant laws and regulations and signed contract between OPTIMAPHARM and Client/ Sponsor.

The SCPM is responsible to:
  • ensure that the activities which have been contracted to OPTIMAPHARM are coordinated effectively to ensure that the project is delivered to the Client/ Sponsor on time, within the budget and within agreed project targets, ensuring that quality standards and expectations are met
  • coordinate and lead the assigned clinical project team and assess the performance of team members according to project deliverables and Key Performance Indicators (KPIs) to ensure efficient and effective project execution
  • ensure effective cross-functional teamwork among local project team members including both internal and external ancillary services (e.g. Regulatory and Safety Department, Finance Department, Quality Assurance and Training Department etc.)
  • contribute to proposal strategy, proposal development and budget preparations
  • promote new business by participating in preparation of project bids and attendance to the Client presentations/meetings (e.g. bid defence meetings) as appropriate and requested by Business Development Department (BDD) and/or senior management.
  • liaise with senior management within the organization to continuously assess and improve operational project delivery
Education

University degree, preferably in life sciences.

Experience and knowledge
  • At minimum 8 years of previous experience on clinical research positions within CRO environment
  • At minimum 3 years of Clinical Project Management experience including experience in managing multi-country clinical trials and teams
  • Excellent knowledge of GCP and ICH Guidelines
  • Excellent knowledge of relevant regulatory requirements
Skills and personality
  • High drive and motivation with strong goal-oriented, persuasive and proactive personality
  • Well organized and structured business approach
  • Developed leadership skills and competencies to organize and supervise project teams
  • Ability to work in a fast-paced, team-oriented environment and strong problem- solving skills
  • Excellent verbal and written communication skills
  • Interest for supporting and participating in business development activities
  • Ambition to develop to senior management positions within the Company

By joining our fast growing and prosperous team, you will have a great opportunity for further personal growth and career development. We offer the possibility to lead international Clinical Project teams and to strongly support the fast growth of the Company across Europe and Israel. We offer a competitive compensation package and the opportunity to work on different international projects in an exciting and vibrant work environment.

We are open to receive applications no matter your current location as the position can be based in any of Company’s offices in Europe.

We are looking forward to receiving your CV.

Please note that only shortlisted candidates that meet the requirements will be contacted for further selection process.

Senior Clinical Project Manager (m/f) - Spain
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If you have vast experience in Clinical Research and your strengths include excellent organisational and people management skills, you are the right fit for the point person in charge of projects at OPTIMAPHARM. Apply today and become a part of our fast growing Project Management team.

The Senior Clinical Project Manager (SCPM) is a member of the international clinical development team that is primarily responsible for the setting up and management of a project according to the protocol and relevant project plans, current GCP ICH guidelines, applicable SOPs, relevant laws and regulations and signed contract between OPTIMAPHARM and Client/ Sponsor.

The SCPM is responsible to:

  • ensure that the activities which have been contracted to OPTIMAPHARM are coordinated effectively to ensure that the project is delivered to the Client/ Sponsor on time, within the budget and within agreed project targets, ensuring that quality standards and expectations are met
  • coordinate and lead the assigned clinical project team and assess the performance of team members according to project deliverables and Key Performance Indicators (KPIs) to ensure efficient and effective project execution
  • ensure effective cross-functional teamwork among local project team members including both internal and external ancillary services (e.g. Regulatory and Safety Department, Finance Department, Quality Assurance and Training Department etc.)
  • contribute to proposal strategy, proposal development and budget preparations
  • promote new business by participating in preparation of project bids and attendance to the Client presentations/meetings (e.g. bid defence meetings) as appropriate and requested by Business Development Department (BDD) and/or senior management.
  • liaise with senior management within the organization to continuously assess and improve operational project delivery
Education

University degree, preferably in medical or life sciences.

Experience and knowledge
  • At minimum 8 years of previous experience on clinical research positions within CRO environment
  • At minimum 3 years of Clinical Project Management experience including experience in managing multi-country clinical trials and teams
  • Experience in different therapeutic areas, onclology/onco-hematology especially
  • mandatory early phases experience, mandatory vaccine experience, vendor and budget management experience
  • Excellent knowledge of GCP and ICH Guidelines
  • Excellent knowledge of relevant regulatory requirements
Skills and personality
  • High drive and motivation with strong goal-oriented, persuasive and proactive personality
  • Well organized and structured business approach
  • Developed leadership skills and competencies to organize and supervise project teams
  • Ability to work in a fast-paced, team-oriented environment and strong problem- solving skills
  • Excellent verbal and written communication skills
  • Interest for supporting and participating in business development activities
  • Ambition to develop to senior management positions within the Company

A current, valid driver’s license would be advantageous (position requires up to 20% of travel)

By joining our fast growing and prosperous team, you will have a great opportunity for further personal growth and career development. We offer the possibility to lead international Clinical Project teams and to strongly support the fast growth of the Company across Europe and Israel. We offer a competitive compensation package and the opportunity to work on different international projects in an exciting and vibrant work environment.

Please send your CV in English and note that only shortlisted candidates that meet the requirements will be contacted for further selection process.

Clinical Research Associate (m/f) – France
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To support the continuous and strong growth in number of projects and to strengthen the Clinical team OPTIMAPHARM is looking for a highly motivated and experienced individual for the position of Clinical Research Associate.

Responsibilities

The Clinical Research Associate (CRA) is a member of the clinical development team who is responsible for all aspects of study site monitoring to ensure that the rights and well- being of human subjects are protected; the reported trial data are accurate, complete and verifiable from source documents, and that the conduct of the trial is in accordance with the currently approved protocol/amendment(s), relevant study specific documentation, Standard Operating Procedures, ICH GCP Guidelines and applicable regulatory requirements. In doing this, the Clinical Research Associate represents Company and the Client/ Sponsor to site personnel and colleagues with professionalism and integrity.

Education

University degree, preferably in medical or life sciences. Individuals with university degree in biotechnical, technical, bio medicinal, social or humanistic sciences must have nursing education or other relevant healthcare college degree

Experience and knowledge
  • Candidates should have at least 3 years of individual clinical trial monitoring experience, experience in oncology studies and medical devices is an advantage
  • High level of knowledge of ICH GCP Guidelines, knowledge of regulatory requirements and a strong interest in clinical research
  • Excellent understanding of clinical trial process
  • Experience in Quality Systems and audit/inspection visits
  • Fluent in local language and in English, both, written and verbal
  • Computer proficiency is mandatory
Skills and personality
  • Ability to read, analyze, and interpret common scientific and technical journals
  • Excellent verbal and written communication skills
  • Affinity to work effectively and efficiently in a matrix environment
  • Ability to work with minimal supervision, pro-active
  • Very good interpersonal and negotiation skills
  • Excellent numerical skills and reasoning ability

A current, valid driver’s license would be advantageous (position requires up to 30% of travel)

By joining our fast growing and prosperous team, you will have a great opportunity for further personal growth and career development. We offer the opportunity to work on international projects and to be a member of international clinical research teams, a competitive salary, lots of training opportunities and flexible working hours.

Please send your CV in English and note that only shortlisted candidates that meet the requirements will be contacted for further selection process.

Clinical Research Associate (m/f) – Germany
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To support the continuous and strong growth in number of projects and to strengthen the Clinical team OPTIMAPHARM is looking for a highly motivated and experienced individual for the position of Clinical Research Associate.

Responsibilities

The Clinical Research Associate (CRA) is a member of the clinical development team who is responsible for all aspects of study site monitoring to ensure that the rights and well- being of human subjects are protected; the reported trial data are accurate, complete and verifiable from source documents, and that the conduct of the trial is in accordance with the currently approved protocol/amendment(s), relevant study specific documentation, Standard Operating Procedures, ICH GCP Guidelines and applicable regulatory requirements. In doing this, the Clinical Research Associate represents Company and the Client/ Sponsor to site personnel and colleagues with professionalism and integrity.

Education

University degree, preferably in medical or life sciences. Individuals with university degree in biotechnical, technical, bio medicinal, social or humanistic sciences must have nursing education or other relevant healthcare college degree

Experience and knowledge
  • Candidates should have at least 3 years of individual clinical trial monitoring experience, experience in oncology studies and medical devices is an advantage
  • High level of knowledge of ICH GCP Guidelines, knowledge of regulatory requirements and a strong interest in clinical research
  • Excellent understanding of clinical trial process
  • Experience in Quality Systems and audit/inspection visits
  • Fluent in local language and in English, both, written and verbal
  • Computer proficiency is mandatory
Skills and personality
  • Ability to read, analyze, and interpret common scientific and technical journals
  • Excellent verbal and written communication skills
  • Affinity to work effectively and efficiently in a matrix environment
  • Ability to work with minimal supervision, pro-active
  • Very good interpersonal and negotiation skills
  • Excellent numerical skills and reasoning ability

A current, valid driver’s license would be advantageous (position requires up to 30% of travel)

By joining our fast growing and prosperous team, you will have a great opportunity for further personal growth and career development. We offer the opportunity to work on international projects and to be a member of international clinical research teams, a competitive salary, lots of training opportunities and flexible working hours.

Please send your CV in English and note that only shortlisted candidates that meet the requirements will be contacted for further selection process.

Clinical Research Associate (m/f) – Austria
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To support the continuous and strong growth in number of projects and to strengthen the Clinical team OPTIMAPHARM is looking for a highly motivated and experienced individual for the position of Clinical Research Associate.

Responsibilities

The Clinical Research Associate (CRA) is a member of the clinical development team who is responsible for all aspects of study site monitoring to ensure that the rights and well- being of human subjects are protected; the reported trial data are accurate, complete and verifiable from source documents, and that the conduct of the trial is in accordance with the currently approved protocol/amendment(s), relevant study specific documentation, Standard Operating Procedures, ICH GCP Guidelines and applicable regulatory requirements. In doing this, the Clinical Research Associate represents Company and the Client/ Sponsor to site personnel and colleagues with professionalism and integrity.

Education

University degree, preferably in medical or life sciences. Individuals with university degree in biotechnical, technical, bio medicinal, social or humanistic sciences must have nursing education or other relevant healthcare college degree

Experience and knowledge
  • Candidates should have at least 2 - 3 years of individual clinical trial monitoring experience, experience in oncology studies is an advantage
  • High level of knowledge of ICH GCP Guidelines, knowledge of regulatory requirements and a strong interest in clinical research
  • Excellent understanding of clinical trial process
  • Experience in Quality Systems and audit/inspection visits
  • Fluent in local language and in English, both, written and verbal
  • Computer proficiency is mandatory
Skills and personality
  • Ability to read, analyze, and interpret common scientific and technical journals
  • Excellent verbal and written communication skills
  • Affinity to work effectively and efficiently in a matrix environment
  • Ability to work with minimal supervision
  • Very good interpersonal and negotiation skills
  • Excellent numerical skills and reasoning ability

A current, valid driver’s license would be advantageous (position requires up to 30% of travel)

By joining our fast growing and prosperous team, you will have a great opportunity for further personal growth and career development. We offer the opportunity to work on international projects and to be a member of international clinical research teams, a competitive salary, lots of training opportunities and flexible working hours.

Please send your CV in English and note that only shortlisted candidates that meet the requirements will be contacted for further selection process.