Job Description

Overview

Title - Clinical Trial Manager

Location - Hybrid (South Africa)

Sponsor dedicated

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organization's.

With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Responsibilities

Site Oversight & Delivery Activities

Establish and manage site relationships, including but not limited to:

• Act as liaison between the company and investigational sites, building investigator and site staff awareness
• Develop and implement a plan, in collaboration with global and local teams, to raise the profile of the company and its global clinical development projects with current and potential investigators
• Independently perform activities associated with the evaluation of investigational sites to build company network
• Proactively work with Medical/Patient/Industry Associations to build company network and to promote company clinical trials
• Develop knowledge of site capabilities and past performance to assess their potential as participating sites in sponsors clinical trials
• Ensure regular communication with local organization to align interactions with KTLs and other relevant local/regional stakeholder

Oversee site-level study start-up, conduct, and close-out activities outsourced to CRO(s) for global programs across Therapeutic Areas, including but not limited to:

• Support Site Agreement negotiations, including stand-alone and Master Site Agreements
• Identify trends, issues and risks across sites, and work with external vendors and internal Trial Team to resolve/mitigate those
• Collaborate with external vendors and internal Trial Team, to ensure that sites are activated in a timely manner and according to agreed timelines
• Collaborate with external vendors and internal Trial Team, to ensure that sites deliver on expected recruitment targets, including identifying reasons for non-recruitment, and identification of non-performing sites that require actions
• Ensure ICH/GCP/local regulatory requirements are observed

In addition, employee may be assigned one or more xe2x80x98added valuexe2x80x99 roles:

Therapeutic Area Expert Assignment

• SME with focus to increase disease knowledge within the team by sharing materials(training/articles/abstracts) and/or arranging training sessions

Country Start-up Specialist Assignment

• Ensure that clinical sites in country(ies) of responsibility are activated within agreed timeframe and company agreed cycle times
• Work closely with respective Clinical Site Leads to support them in issue resolution for site activation
• Collaborate with external vendors to identify process(es) requiring improvement at the Country level, build action plans to strengthen/improve those and track impact of actions
• Support OSM model by acting as a local SME

Clinical Trial Delivery Lead Assignment

• Identify trends and issues within/across assigned trial(s) which may impact key deliverables (e.g. timelines/quality/costs) and implement action plans to either resolve and/or mitigate those
• Advise the Trial Team on trends/issues and facilitate solutions, working closely with the CTL to ensure Corrective & Preventive Actions are defined and implemented. Raise awareness of such trends/issues with Clinical Site Leads and other internal and external stakeholders as appropriate
• Develop, implement and follow up on strategic action plans to drive improvements in site activation and/or enrolment, in collaboration with the CTL, CRO(s) and working closely with the respective Clinical Site Leads
• Participate in Investigator/Study Coordinator Meetings and promote information sharing with the Clinical Site Leads as needed

Oversee external providers as applicable

EXTERNAL COLLABORATION

• Ethics Committees/ Regulatory Authorities
• Hospital administration
• Pharma Industry working groups
• Vendors (CRO)
• Clinical Research trial sites (Institutions/Investigators)

Qualifications

WORK EXPERIENCE

• Experience in clinical development/operations (minimum of 8 years) including at least 3 years of experience in oversight of vendors and project management (applicable for experienced Project Manager or Clinical Trial Manager)
• Detailed understanding of all aspects of clinical protocol design and implementation, clinical site monitoring as well as overall global drug development
• Expert knowledge of clinical development (principles and concepts as well as regulatory environment e.g. ICH GCP and applicable regional/local regulations)
• Oncology and/or Neurology and/or Immunology TA experience desired
• Requires graduate background (Medical or Life Sciences degree) in a clinical research related discipline or equivalent

COMPETENCIES & SKILLS

• Strong communication skills (verbal, written and listening) in both native language and English
• Aptitude to interpret and to integrate site performance data in prioritization of oversight activities
• Ensuring compliance with applicable T&E Policy requirements
• Role requires domestic and international travel up to 50% of time

What ICON can offer you:

Our success depends on the quality of our people. Thatxe2x80x99s why wexe2x80x99ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your familyxe2x80x99s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your familyxe2x80x99s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request .

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless xe2x80x93 therexe2x80x99s every chance youxe2x80x99re exactly what wexe2x80x99re looking for here at ICON whether it is for this or other roles.

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