Early Development & Clinical Pharmacology (ED&CP) Trial Manager Job

Job description

Early Development & Clinical Pharmacology (ED&CP) Trial Manager-1500049602WDescriptionTrial Manager, Oncology & Early DevelopmentAt Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases, vaccines, cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson (J&J). Please visithttp://www.janssen.co.uk/ for more information.
Position Title: Early Development & Clinical Pharmacology (ED&CP) Trial ManagerGCF: 26Location: UK, High WycombeClosing Date: Monday 27th July 2015What type of mark will you make?Your unique talents and perspective can make a vital contribution to innovative products that improve the lives of people everywhere. Career opportunities within Johnson & Johnson companies may provide you with an ideal setting to build your experience; express your passion and touch the world.
The Early Development & Clinical Pharmacology (ED&CP) Trial Manager (TM) is responsible for the local management of a trial in one or more countries and to deliver quality data and trial documents/records that are compliant with assigned protocol, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs) and regulatory requirements.
You will act as the primary point of contact at a country level for assigned studies.
The TM performs the Local Trial Manager (LTM) tasks including operational oversight of assigned protocol(s) from start-up to database lock and closeout activities as described in GCO procedural documents.
The TM performs the Global Trial Manager (GTM) tasks as described in GCO procedural documents for ED&CP studies to which no GTM has been assigned.
The TM may perform the Site Manager (SM) tasks as described in GCO procedural documents for ED&CP studies.
The TM actively contributes to process improvement initiatives, and training and mentoring of Site Managers and Clinical Trial Assistants.
Responsibilities :1. Besides the LTM tasks, a TM may also be responsible for GTM and SM tasks depending on the studies assigned. For the GTM and SM tasks reference is made to the Job Description for the ED&CP GTM and SM and the GCO Procedural Documents.2. Is responsible for study feasibility and site/lab assessments, providing recommendation of suitable sites for selection to participate in the trial. Ensures appropriate follow-up of pre-trial visit report.3. Collaborates with the CPL, GTM, functional management and Protocol Owner to select final site list.4. Contributes input to the development of e.g. the Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at a country level or initiates development of these plans for trials to which no GTM is assigned.5. Ensures that all SAEs/PQCs are reported within reporting timelines and documented as appropriate.6. Maintains and updates trial management systems (e.g. CTMS, eTMF/LAF, Trial Master Source and SharePoint sites). Uses study tools and management reports available to analyze trial progress.7. Monitors country progress and initiates corrective and preventive actions when the trial deviates from plans and communicates study progress and issues to CPL,GTM, protocol owner and study management teams e.g. ensures appropriate documentation and follow-up related to protocol issue escalation.8. May submit requests for vendor services and may support vendor selection. Reviews and approves site and local vendor invoices as required9. May lead negotiation of trial site contracts and budgets. May be responsible for forecasts and management of GCO budget to ensure accurate finance reporting and trial delivered within budget. Adheres to finance reporting deliverables and timelines.10. Accountable for set-up and conduct of Investigator Meetings.11. Conducts local trial team meetings and provides or facilitates SM training when needed (i.e. implementation of study amendment-and changes in study related processes).12. Reviews and approves Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a trial project and escalates deviation issues to the GTM and FM as needed.13. Reviews and approves site and local vendor invoices as required.14. Works with SM to ensure CAPAs are developed and implemented for audits and inspection or any quality related visits15. Complies with relevant training requirements.16. Acts as expert for assigned protocols. Develops therapeutic knowledge to support roles and responsibilities. May represent Global Clinical Operations on cross functional teams.17. Acts as primary local contact in GCO for a trial. Establishes and maintains excellent working relationships with GTM, external stakeholders, in particular investigators, trial coordinators, other site staff, key contacts in Early Development and/or Clinical Pharmacology and other internal stakeholders.18. Actively contributes to process improvement initiatives, and training and mentoring of Site Managers and Clinical Trial Assistants.
Qualifications4-year University degree in Life Sciences, Nursing, or related scientific field is required.
Minimum five years of pharmaceutical and/or clinical trial experience is preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
Oncology experience would be advantageous.
Should have solid understanding of the drug development process including ICH/GCP and local regulatory requirements. Solid communication and computer skills required. Proficient in speaking and writing the country language and English language. Good written and oral communication skills.
Occasional regular overnight stay 2 days per week office-based.
Flexible mindset and ability to work at a fast pace within small exploratory study teamsAbility to work on multiple trials in parallel in different disease areas.
Primary Location:Europe/Middle East/Africa-United Kingdom-England-High WycombeOrganization: Janssen Cilag Ltd. (7360)Job Function: Clinical Trial Administration