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26 days old

Global Trial Leader - Medical Affairs Operation

Kelly Services
Raritan, NJ 08869
**Overview:**


The Global Trial Leader MAO (GTL MAO) provides global, regional or complex local management of a clinical trial (s) in a country or countries. Services/deliverables include operational oversight of assigned project(s) at the country level for end to end project management including start-up, execution, close-out, analysis and reporting. Further, services will ensure the teams operational activities are in line with country specific regulations and trial teams are delivering high 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 Program Leader (CPL), Clinical Operations Head (COH), Global Clinical Trial Assistant (GCTA), and other Global Trial Leaders (GTL) to ensure overall study delivery at the country level.


Therapeutic Area - vaccine, neuro science and infectious disease.


This role requires high level of interaction with R&D (data integration) particularly for the very early phases of the compound


This is a Multi-phase, Phase I-III, working in a interventional and non-interventional setting


**Deliverables:**


+ Services rendered will adhere to applicable Johnson & Johnson SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.

+ Complies with relevant training requirements.

+ Prepares high level budget estimate in response to Request for Services followed by detailed budget proposal.

+ Ensures accurate trial budget management, updates for scope changes and reconciliation of assigned trials for both Out of Pocket (OOP) costs and FTE costs.

+ Responsible for overall contract management, including review and approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract.

+ Act as primary company contact for assigned trial at the country level and ensures local/country team is tracking project progress against planned timelines and monitors patient recruitment rate to ensure that target enrollment will be met across the allocated countries. This may require development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.

+ Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress.

+ Participates in preparation for and conduct of Health Authority (HA) inspections and internal Quality Assurance audits.

+ Escalates corrective and preventive actions (CAPA) to GTL and CPL when the trial deviates from plans and communicates study progress and issues to study management teams and business partners.

+ Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target and works with GCO/CRO staff in the set up and coordination of Investigator meetings, if applicable.

+ Delivers competent vendor management at the country level to support the study and may submit requests for vendor services and support vendor selection. This includes reviewing and approving site and local vendor invoices as required. As required, manages the local study drug supply.

+ Contributes to patient understanding of protocol and patient safety by contributing to the review of country specific informed consent in accordance with procedural document/templates. This includes creating, reviewing and managing site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations. x Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented, as appropriate.

+ Ensures Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS and VTMF) according to expectations (metrics) and archiving retention requirements where applicable.

+ With focus on quality, participates in preparation for, and conduct of, HA inspections and Internal Quality Assurance (QA) audits. Works closely with CPL to ensure CAPA is implemented for audits/inspections or any quality related issues or concerns.

+ Ensures accurate finance reporting and trial delivered within budget by adhering to finance reporting deliverables and timelines. This includes forecasting and proactive management of country/local trial budget. If applicable, may assist in negotiation of trial site contracts and budgets.

+ Keeps the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals, if applicable.

+ May contribute as a mentor, champion, or representative of functional area in process initiatives, as required and if applicable.

+ If applicable, region specific deliverables will be specified.


**Advanced:**


+ Autonomy with execution of Global, Regional and local trial management services.

+ Depth of knowledge with Global, Regional and local trial management services.

+ Process leadership. Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document.


**Requirements:**


+ Bachelors degree or equivalent required, preferably in Life Sciences.

+ Experience in both non-interventional and interventional studies highly preferred

+ 8 years of clinical research experience in the pharmaceutical industry or CRO.

+ Capability to interact heavily with R&D (data integration) particularly for the very early phases of the compound

+ Project/Program management and/or end to end global trial operational experience required

+ 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.

+ Excellent decision-making and strong financial management skills.

+ Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate.

+ Previous line management experience is a plus, but not required.

+ Flexibility and ability to manage study teams in a virtual environment.

+ Other relevant experiences and skills may be considered.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-04-22 Expires: 2022-05-23

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Global Trial Leader - Medical Affairs Operation

Kelly Services
Raritan, NJ 08869

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