Vacancies

Title

Senior Clinical Research Associate (SCRA)

Location

Lebanon

Principal Duties and Responsibilities

  • Maintains knowledge and ensures compliance with ICH-GCP, regulatory requirements, applicable guidelines, SOPs, project specific procedures and project scope, budget, etc. (e.g. Project and Monitoring Plan)
  • Ensures timely completion of role based and project specific trainings
  • Supports timely selection of qualified investigational sites (with clinical project manager/project team)
  • Builds strong and lasting relationships with site investigators and site teams/staff
  • Schedules, plans, prepares for and then performs site monitoring visits according to the monitoring plan and SOPs to ensure appropriate monitoring activities are completed at each onsite or remote visit (e.g. SDV, site staff training, investigator site file review, compliance checks, drug accountability, observational visits, facility review, etc.).
  • Applies judgment and knowledge to independently resolve sites issues, questions and concerns
  • Provides timely updates to tracking systems/clinical trial management system (CTMS) as needed
  • Collects, compiles and reviews new/updated/amended site regulatory package (SRP) documents in collaboration with Clinical Trial Specialists (CTS)/project team on an ongoing basis
  • Submits to and follows up with site staff on Clinical Site Agreements (CSA) (including budget), and site-specific Informed Consent Forms (ICF)
  • Provides prepared EC package to the Principal Investigator (PI) for submission and follows up to secure approval where required
  • Plans and evaluates patient recruitment, reviews and provides updates to applicable project tracking systems
  • Reviews subject safety data and AEs/SAEs and ensures appropriate follow-up and escalation according to protocol/regulatory requirements
  • Responds to site issues, ascertains and recommends appropriate follow-up response to issues including potential deficiencies in documentation, communication, and the need for additional training
  • Evaluates overall compliance and performance of sites and site staff: provides recommendations regarding site-specific actions and uses judgment and experience to assess the ability and motivation of site staff
  • May assist Project Manager or clinical team manager on assigned projects and/or may assist in the mentoring and training of junior clinical team members.
  • Other duties as needed or required

Supervision Received

The candidate should report to the Line Manager, with regular/close supervision.

Requirements

  • Bachelor’s degree in a science related field or equivalent certification/licensure from an appropriately accredited institution
  • Minimum 3 years of experience as CRA (clinical research monitoring experience that provides the required knowledge, skills and abilities and experience mentoring or training others)
  • Valid Driver’s License where applicable
  • An equivalent combination of education, professional training, and experience that provides the required knowledge, skills and abilities may be considered
  • Deals with confidential information and/or issues using discretion and judgment

Other Qualifications & Skills

  • Effective clinical monitoring skills
  • Excellent understanding and demonstrated application to FDA 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
  • 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
  • Effective verbal and written communication skills, with the ability to communicate effectively with medical personnel
  • Good command of English language and grammar
  • Flexibility to travel

Ending message

If you believe you can make an impact by joining a dynamic and multicultural team, we ask you to APPLY NOW and join our team.

Title

Clinical Operations Manager

Location

Lebanon or Egypt

Principal Duties and Responsibilities

  • Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems.
  • Lead, develop, coach, and motivate CTAs, CRAs and PMs to develop their skills to ensure that a high professional standard is achieved and project targets are met.
  • Ensure timely and accurate reporting of required information on company systems.
  • Participate in the selection process for new staff by conducting candidate review and participating in the interviewing process. Conduct on-boarding training for new staff in conjunction with Human Resources and Learning and Development training programs.
  • Coordinates internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical trials
  • Develop and manage study timelines (including recruitment) and may develop and manage program timelines
  • Participates in the selection of investigational sites with input from Clinical/Medical Operations and vendors
  • Identifies and provides solutions to clinical trial issues and/or risks
  • Provide or facilitate training to clinical study teams on assigned protocol specific topics
  • Work closely with other teams in the organization, e.g. Quality,Regulatory, etc.
  • Provide input into non-project related activities and development of department processes, procedures, and guidelines as requested

Supervision Received

The candidate should report to the CEO, with regular/close supervision.

Requirements

  • BS or Master’s Degree in life science, or related field (or equivalent experience)
  • Minimum of 7 years of clinical research experience, at least 3 of which are as a Project Manager for clinical studies at a CRO and/or pharmaceutical/biotech organization
  • Previous experience negotiating vendor/site contracts and managing the budgets
  • Thorough understanding of FDA, ICH and GCP guidelines
  • Experience with Phase I -IV clinical trials
  • Proven track record showing clear proficiency in clinical project management skills
  • Solid vendor management skills, e.g. CRO, Laboratory & Clinical supply logistics
  • Broad understanding of clinical operations related to clinical development functions
  • Ability to effectively interface with medical personnel at clinical site(s)
  • Ability to lead multi-disciplinary, cross-functional teams both internally & externally
  • Detail and team oriented with excellent cross-functional team leadership and participation skills
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Ability and willingness to travel 25% of the time

Ending message

If you believe you can make an impact by joining a dynamic and multicultural team, we ask you to APPLY NOW and join our team.

Title

Clinical Research Associate

Location

Kingdom of Saudi Arabia

Principal Duties and Responsibilities

  • Maintains knowledge and ensures compliance with ICH-GCP, regulatory requirements, applicable guidelines, SOPs, project specific procedures and project scope, budget, etc. (e.g. Project and Monitoring Plan)
  • Ensures timely completion of role based and project specific trainings
  • Supports timely selection of qualified investigational sites
  • Builds strong and lasting relationships with site investigators and site teams/staff
  • Provides timely updates to tracking systems/clinical trial management system (CTMS) as needed
  • Plans and evaluates patient recruitment, reviews and provides updates to applicable project tracking systems
  • Reviews subject safety data and AEs/SAEs and ensures appropriate follow-up and escalation according to protocol/regulatory requirements
  • Other duties as needed or required

Supervision Received

The candidate should report to the Clinical Project Manager and Line Manager, with regular/close supervision.

Requirements

  • Bachelor’s degree in a science related field or equivalent certification/licensure from an appropriately accredited institution
  • Minimum 1 year of experience as CRA
  • Valid Driver’s License where applicable
  • An equivalent combination of education, professional training, and experience that provides the required knowledge, skills and abilities may be considered
  • Deals with confidential information and/or issues using discretion and judgment

Other Qualifications and Skills

  • Effective clinical monitoring skills
  • Excellent understanding and demonstrated application of FDA guidelines, Good Clinical Practices and applicable Standard Operating Procedures
  • Ability to evaluate medical research data and proficient knowledge of medical terminology
  • 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
  • Effective verbal and written communication skills, with the ability to communicate effectively with medical personnel
  • Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software
  • Good command of English language and grammar
  • Flexibility to travel

Ending message

If you believe you can make an impact in the global research, we ask you to APPLY NOW and join our team.

Title

Clinical Research Associate

Location

Bahrain

Principal Duties and Responsibilities

  • Maintains knowledge and ensures compliance with ICH-GCP, regulatory requirements, applicable guidelines, SOPs, project specific procedures and project scope, budget, etc. (e.g. Project and Monitoring Plan)
  • Ensures timely completion of role based and project specific trainings
  • Supports timely selection of qualified investigational sites
  • Builds strong and lasting relationships with site investigators and site teams/staff
  • Provides timely updates to tracking systems/clinical trial management system (CTMS) as needed
  • Plans and evaluates patient recruitment, reviews and provides updates to applicable project tracking systems
  • Reviews subject safety data and AEs/SAEs and ensures appropriate follow-up and escalation according to protocol/regulatory requirements
  • Other duties as needed or required

Supervision Received

The candidate should report to the Clinical Project Manager and Line Manager, with regular/close supervision.

Requirements

  • Bachelor’s degree in a science related field or equivalent certification/licensure from an appropriately accredited institution
  • Minimum 1 year of experience as CRA
  • Valid Driver’s License where applicable
  • An equivalent combination of education, professional training, and experience that provides the required knowledge, skills and abilities may be considered
  • Deals with confidential information and/or issues using discretion and judgment

Other Qualifications and Skills

  • Effective clinical monitoring skills
  • Excellent understanding and demonstrated application of FDA guidelines, Good Clinical Practices and applicable Standard Operating Procedures
  • Ability to evaluate medical research data and proficient knowledge of medical terminology
  • 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
  • Effective verbal and written communication skills, with the ability to communicate effectively with medical personnel
  • Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software
  • Good command of English language and grammar
  • Flexibility to travel

Ending message

If you believe you can make an impact in the global research, we ask you to APPLY NOW and join our team.