Clinical Trial Manager

As a (Local Trial Manager) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence

Services Overview:  
 Local Trial Management services, provides local management of a clinical trial (or Medical Affairs data 
generation activity) in a country or countries. Services/deliverables include operational oversight of 
assigned protocol(s) at the country level from start‐up through to database lock and closeout activities. 
Further, services will ensure the local trial team is delivering quality data and trial documents/records 
that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures 
(SOPs), International Conference on Harmonization for Good Clinical Practice (ICH‐GCP), and regulatory 
requirements. Partners with the Clinical Trial Assistant (CTA)/Investigator Document Assistant (IDA), Site 
Manager (SM) and Central Trial Manager (CTM)/Global Trial Manager to ensure overall study delivery at 
the country level.  
 
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Services rendered will adhere to applicable Johnson & Johnson SOPs, WIs, policies, local regulatory 
requirements, etc.  
 Analyze requirements and translating into appropriate contracts and budgets for clinical trial 
agreements and other relevant legal documents. Review all study specific tracking requirements for 
accuracy and completeness as well as delivering against contracting cycle time targets.  
 Work with global teams to review and analyze contractual terms and conditions.  Assess legal and 
budget risks in conjunction with team support functions.  Partner with Healthcare Compliance, Risk 
Management, Privacy and other stakeholders to obtain guidance and drive resolution.  Escalate as 
appropriate. 
 Provide specialized support and guidance on negotiations in confidentiality agreements, informed 
consent forms and other ancillary contract documents, as required.  
 Analyze investigator fees in relation to fair market value pricing and ensure alignment with regional 
standards and the J&J pricing guidelines.  Participate in and/or lead approval escalations as 
appropriate. 
 Determine potential needs for contract amendments and manage amendment lifecycle. Ensure that 
contractual terms and provisions follow corporate process, systems, and strategies.   
 Provide project management oversight to CROs contracted to negotiate CTAs globally, inclusive of 
training and supervision to ensure adherence to timelines/targets.   
 Onboard and train new flex staff (will require in person training as well as remote) and meet 
regularly with team members to ensure studies are properly supported and identify contracting 
issues and potential solutions. Assist in resolution of site/study related concerns. Mentor and guide 
teams on processes and procedures. 
 Liaise with management on staff performance and development. Facilitate clear and consistent 
communications between management and other team members.  Identify and implement process 
improvements.  Drive accountability and results.  Assist in review, authorization and/or 
management of payments as requested.  Assist clinical operations or clinical team in ensuring that 
investigator grants comply with overall study costs and compliance guidelines. 
 Adhere to SOPs, ethics and departmental compliance as determined by GCDO management as well 
as operating companies, corporate, HCC and QA guidelines.  Ensure familiarity with departmental 
and corporate processes including but not limited to the relevant processes associated with CCS 
GCDO and operating companies. Comply with requests from QA and auditors. 

Ensures Inspection readiness by maintaining complete, accurate and timely data and essential 
documents in systems utilized for trial management (e.g. SATS) according to expectations 
(metrics) and archiving retention requirements.  
Ensure inspection ready. Comply with relevant training requirements and developing 
therapeutic knowledge to ensure service delivery. 
May contribute as a mentor, champion, or representative of functional area in process 
initiatives, as required. 
Full utilization by timely and accurate time reporting (BEACON).  

Education and Experience Guidelines:  
 BA/BS degree. 
 Degree in a health or science related field. 
 2 years of local trial management experience. 
o Advanced: 3 to 5+ years of trial management experience. 
 Specific therapeutic area experience may be required depending on the position. 
 Strong working knowledge of ICH‐GCP, company standard operating procedures, local laws and 
regulations, assigned protocols and associated protocol specific procedures. 
 Strong IT skills in appropriate software and company systems. Willingness to travel with 
occasional overnight stay away from home according to business needs.  
 Proficient in speaking and writing the country language and English. Good written and oral 
communication skills as appropriate.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve 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 family’s 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 family’s 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

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.