Careers at ESTERN Medical

U.S. North America

1. Senior Clinical Research Associate Level II & III (Remote)

Locations: US North America-United States.

Requisition ID: EM-US-SR-CRA- RM- 1003

Job Description

The experienced Senior Clinical Research Associate (CRA) Remote, performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA/EMEA/ and preferably some knowledge of Latin America/South American local guidelines, local regulations and ESTERN Medical Standard Operating Procedures and experience. Experience in Pharmaceuticals / Medical Devices.

The Sr. CRA will conduct site visits to assess protocol and regulatory compliance and manages required documentation. Responsible for ensuring that data will pass international quality assurance audits. Represents ESTERN Medical in the global medical research community and develops and maintains collaborative relationships with investigational sites and client company personnel. May assist project manager or clinical team manager on assigned projects and/or may assist in the mentoring and training of junior clinical team. Required to travel 25-50%

Requirements

Education & Experience:

Bachelor’s degree in a science related field or a Registered Nursing certification or equivalent certification/licensure from an appropriately accredited institution with significant clinical research monitoring experience (comparable to at least 3-5 years) that provides the required knowledge, skills and abilities and experience mentoring or training others.

In some cases an equivalent combination of education, professional training, and experience that provides the required knowledge, skills and abilities may be considered.

Knowledge, Skills and Abilities:

• Effective clinical monitoring skills

• Excellent understanding and demonstrated application of FDA/EMEA and preferably some Latin American/South American guidelines, Good Clinical

• Practices and applicable Standard Operating Procedures

• Ability to mentor and train other monitors in a positive and effective manner

• Ability to evaluate medical research data and proficient knowledge of medical terminology

• Effective oral and written communication skills, with the ability to communicate effectively with medical personnel

• Strong customer focus

• Excellent interpersonal skills

• Strong attention to detail

• Effective organizational and time management skills

• Proven flexibility and adaptability

• Excellent team player with team building skills

• Ability to work independently as required

• Ability to utilize problem-solving techniques applicable to constantly changing environment.

• Good computer skills:

• Good knowledge of Microsoft Office and the ability to learn appropriate software

• Excellent English and also preferably knowledge of some mid level Spanish or Portuguese language and grammar skills

• Effective presentation skills

• Therapeutic expertise in Cardiovascular, CNS, Oncology, Ophthalmology, Infectious Diseases, Diagnostic Imaging, Pain Management and/or other.

Work wit Us

2. Senior Project Manager (Remote)

Locations: US North America-United States.

Requisition ID: EM-US-SR-PM- RM- 1003

Job Description

Serve as Clinical Project Manager for international projects Phase I, II, III, IV for Pharmaceutical & Medical Device projects, according to ESTERN Medical Standard Operating Procedures, ICH Guidelines and GCP with total responsibility.

• Responsible for the successful conduct of assigned projects.

• Serve as Project Manager for assigned business development opportunities.

• Liaise with senior management in the Delivery and Service Centers to ensure adequate resources are available for assigned projects.

• Responsible for on time, on-budget provision of client deliverables for assigned projects.

Education/Qualifications

Required:

• University/college degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).

• Detailed knowledge of financial control procedures

• Thorough knowledge of project management processes.

• Thorough knowledge of time and cost estimate development.

• Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.

• Fluent in English & Spanish, both written and verbal.

• Broad knowledge of drug development process and client needs.

• English & Spanish Written & Verbally.

Preferred:

• Masters or other advanced degree.

• Detailed knowledge of ESTERN Medical and the overall structure of the organization.

• Basic knowledge of ESTERN Medical sales and business development strategies and procedures.

• Thorough knowledge of ESTERN Medical S.O.P.s

Experience Required

• Minimum of seven (7) years relevant clinical research experience in a pharmaceutical company/CRO, including at least four (4) years of full project management responsibility.

• In lieu of the above requirement, candidates with > five (5) years supervisory experience in a heath care setting and > five (5) years clinical research experience including two (2) years of project management experience (international clinical trial management experience preferred) in the pharmaceutical or CRO industries will be considered.

• Experience in managing global (inter-continental) programs in a multi-office environment.

• Demonstrated ability to handle multiple competing priorities; utilize resources effectively.

• Financial awareness and ability to actively manage financial tracking systems.

• Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system.

• Demonstrated ability to lead by example and to encourage team members to seek solutions.

• Excellent communication, planning and organizational skills.

• Ability to work independently.

• Ability to negotiate and liaise with clients in a professional manner.

• Excellent computer skills with ability to understand and assess technology alternatives and implication for current processes.

• Therapeutic expertise, in Cardiovascular, CNS, Oncology, Diagnostic Imaging, Pain Management and other.

Work wit Us

Latin America

1. Remote Clinical Research Associate Level II & III

Locations: Mexico / Chile / Colombia / Argentina / Brazil.

Requisition ID: EM-RM-SR-CRA-1005

Job Description

Job Summary:

The experienced Senior Clinical Research Associate (CRA) performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA/EMEA/LA local guidelines, local regulations and ESTERN Medical Standard Operating Procedures. Conducts Remote site visits to assess protocol and regulatory compliance and manages required documentation. Responsible for ensuring that data will pass international quality assurance audits. Represents ESTERN Medical in the global medical research community and develops and maintains collaborative relationships with investigational sites and client company personnel. May assist project manager or clinical team manager on assigned projects and/or may assist in the mentoring and training of junior clinical team

Requirements

Education & Experience:

• Bachelor’s degree in a science related field or a Registered Nursing certification or equivalent certification/licensure from an appropriately accredited institution. Significant clinical research monitoring experience (comparable to at least 3-5 years) that provides the required knowledge, skills and abilities and experience mentoring or training others.

• In some cases an equivalent combination of education, professional training, and experience that provides the required Knowledge, Skills and Abilities may be considered.

Knowledge, Skills and Abilities:

• Effective clinical monitoring skills

• Excellent understanding and demonstrated application of FDA/EMEA and local LA guidelines, Good Clinical Practices and applicable Standard Operating Procedures

• Ability to mentor and train other monitors in a positive and effective manner

• Ability to evaluate medical research data and proficient knowledge of medical terminology

• Effective oral and written communication skills, with the ability to communicate effectively with medical personnel

• Strong customer focus

• Excellent interpersonal skills

• Strong attention to detail

• Effective organizational and time management skills

• Proven flexibility and adaptability

• Excellent team player with team building skills

• Ability to work independently as required

• Ability to utilize problem-solving techniques applicable to constantly changing environment.

• Good computer skills:

• Good knowledge of Microsoft Office and the ability to learn appropriate software

• Good English, Spanish or Portuguese language and grammar skills

Work wit Us

2. Regional Project Manager

Locations: Mexico / Chile / Colombia / Argentina / Brazil.

Requisition ID: EM-R-C- PROJ-M-1003

Job Description

Serve as Clinical Project Manager for international projects Phase I, II, III, IV for Pharmaceutical & Medical Device projects, according to ESTERN Medical Standard Operating Procedures, ICH Guidelines and GCP with total responsibility.

• Responsible for the successful conduct of assigned projects.

• Serve as Project Manager for assigned business development opportunities.

• Liaise with senior management in the Delivery and Service Centers to ensure adequate resources are available for assigned projects.

• Responsible for on time, on-budget provision of client deliverables for assigned projects.

Education/Qualifications

Required:

• University/college degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).

• Detailed knowledge of financial control procedures

• Thorough knowledge of project management processes.

• Thorough knowledge of time and cost estimate development.

• Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.

• Fluent in English & Spanish, both written and verbal.

• Broad knowledge of drug development process and client needs.

• English & Spanish Written & Verbally.

Preferred:

• Masters or other advanced degree.

• Detailed knowledge of ESTERN Medical and the overall structure of the organization.

• Basic knowledge of ESTERN Medical sales and business development strategies and procedures.

• Thorough knowledge of ESTERN Medical S.O.P.s

Experience Required

• Minimum of seven (7) years relevant clinical research experience in a pharmaceutical company/CRO, including at least four (4) years of full project management responsibility.

• In lieu of the above requirement, candidates with > five (5) years supervisory experience in a heath care setting and > five (5) years clinical research experience including two (2) years of project management experience (international clinical trial management experience preferred) in the pharmaceutical or CRO industries will be considered.

• Experience in managing global (inter-continental) programs in a multi-office environment.

• Demonstrated ability to handle multiple competing priorities; utilize resources effectively.

• Financial awareness and ability to actively manage financial tracking systems.

• Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system.

• Demonstrated ability to lead by example and to encourage team members to seek solutions.

• Excellent communication, planning and organizational skills.

• Ability to work independently.

• Ability to negotiate and liaise with clients in a professional manner.

• Excellent computer skills with ability to understand and assess technology alternatives and implication for current processes.

• Therapeutic expertise, in Cardiovascular, CNS, Oncology, Diagnostic Imaging, Pain Management and other.

Work with Us

3. Regional Regulatory Manager

Locations: Mexico / Chile / Colombia / Argentina / Brazil.

Requisition ID: EM-R-CT -R-M – 1001

Job Summary

General Purpose and Scope

• To provide an expert scientific consultancy and regulatory service to clients for pharmaceuticals and related areas by assisting with identifying and processing potential sources of business into projects with revenue.

• Specific skills for this job holder include the ability to work on various assignments simultaneously, with no direct supervision as well as providing a “stand-alone” expertise which has a vital input towards the budget of the group.

• To be directly responsible for achieving agreed revenue targets for assigned project work and thus have a direct impact on the revenues of the group.

• To assist in developing new and supporting existing client relationships and acquiring revenue-earning projects.

• To review and critically assess regulatory and/or safety data and provide expert advice and guidance both internally and externally.

• To take decisions and make opinions on scientific and regulatory issues and provide strategic comments within sponsored projects and to communicate these orally and in writing to the client.

• To organize and manage regulatory documentation, literature/safety data reviews and position papers.

• To liaise directly with personnel within ESTERN Medical and other ESTERN Medical Business Units to successfully maintain and generate revenue-earning projects.

• To co-operate with ESTERN Medical personnel, external clients and regulatory authorities in order to support the provision of the necessary documentation and services to the required standard and in a timely fashion.

• To maintain expertise in appropriate scientific disciplines through participation in relevant scientific and regulatory meetings.

• Assist in the training of junior staff within the group.

• To comply with Quality Standards which may be required by ESTERN Medical.

Specific Duties and Responsibilities

The Pharmaceutical section of the Scientific & Regulatory Consulting Group provides a specialist service for clients requiring scientific consultancy advice and in document support for new product registrations & local MoH clinical trials submissions for new indications INDs, NDAs , Phases I, II, III, IV It is the role of the job holder to:

1. Contribute to the development of new and existing clinical projects such that agreed revenue targets can be met and spin-off work for other ESTERN Medical units is encouraged.Project (revenue) work will arise through repeat business, referrals from other colleagues (within and outside Regulatory Services) and from self-generated projects for products including conventional pharmaceuticals, biotechnology products and medical devices. The job-holder will be directly responsible for achieving revenue targets for this project work. The job-holder will be expected to prepare necessary project contracts/paperwork, show awareness on pricing and following-up on non-revenue project issues.

2. Actively demonstrate the potential to employ sales/business development skills to develop new clients for pharmaceutical consultancy work based on ESTERN Medical regulatory and scientific expertise.This role involves meeting clients largely through self-activity to explain ESTERN Medical consultancy and regulatory services, namely the provision of expert advice and the provision of regulatory documentation. Liaison with other areas within ESTERN Medical from which project work may arise (eg, Business Development, Toxicology Department, Programme Management and the Leeds Clinic) will also be involved. A degree of travel and/or presentations to clients and/or at meetings (internally and externally) are expected. The job-holder is also expected to show initiative in exploring other potential areas of revenue from existing clients and/or within on-going projects.

3. Process the results of project work by providing consultancy advice and/or regulatory documentation as well as liaising with the Regulatory Authorities (eg, FDA, EMEA, Local geographic specific EC/IRB’s & MoH’s- submissions in Latin America) on behalf of clients.Skills needed for processing project work will involve decision- and opinion-making through oral communication and written expert advice within a consultancy role and the ability to review regulatory and/or safety data and present an expert opinion both internally and externally. The job-holder will also need to prepare regulatory documentation (eg, Investigator’s Brochures, CTAs and relevant sections within INDs, NDAs, PMA’s, 510Ks), literature/safety data reviews and position papers. This latter role involves reviewing existing data as authorized by a client, provided by the client or from sources within ESTERN Medical and, where necessary, data from the public domain. Other aspects include peer-review of pre-clinical documentation prepared by other members of the department.

4. Provide expert regulatory advice to other ESTERN Medical departments.

5. Act as Program Manager if required.

6. Comply with the requirements Quality Standards which may be required by ESTERN Medical

Supervisory Responsibility

None.

Principal Contacts

Primarily, external contacts will be with new or existing clients and staff from regulatory agencies.

Internal contacts will include the Head of Regulatory Affairs, to discuss projects and future work within the Scientific & Regulatory Consulting group, Business Development, Toxicology Department, Program Management and the Leeds Clinic. Contact with other areas within ESTERN Medical with a need for consultancy/regulatory services will also be expected.

Business opportunities and workload will be discussed at regular in-house group meetings.

Special Factors

In order to fulfill the role of Regulatory Manager, the job-holder must maintain an up to date knowledge of developing regulatory/registration requirements within Latin America (Mexico, Colombia, Chile, Argentina, Peru and Brazil) EU, and USA.

Travel Required 10-15%

Education / Experience / Skills

Required

• Educated to at least BSc level in a relevant life-science subject.

• Previous experience (approx. 7 years) in preclinical drug development gained within industry, academia or contract research or approx. 5 years experience gained in a similar role.

• Excellent communication skills (written and oral).

• Proven ability to demonstrate communication/interpersonal skills necessary for client contact and the potential to develop in sales/business development.

• Excellent planning and organizational skills. full knowledge computer skills.

• Proficient full English & Spanish written & verbal

Work with Us