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Sr Trial Manager Early Development

hace 3 meses

Madrid, España Johnson And Johnson A tiempo completo

Global Clinical Operations (GCO) ED&CP Trial Manager II* (*Title may vary based on Region or Country requirements) Position Summary: The Early Development & Clinical Pharmacology (ED&CP) Trial Manager II (TM II) 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 clinical protocol, codes of Good Clinical Practice (GCP), Healthcare Compliance Requirements (HCC), Standard Operating Procedures (SOPs) and local regulatory requirements.
He/she acts as the primary point of contact at a country level for assigned studies.
The TM II 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 II may perform the Global Trial Leader (GTL) tasks as described in GCO procedural documents for ED&CP studies which follow the ED&CP hybrid oversight model.
The TM II may perform the Site Manager (SM) tasks as described in GCO procedural documents for ED&CP studies.
The TM II actively contributes to process improvement initiatives, and training and mentoring of SMs and Clinical Trial Assistants (CTA).
Principal Responsibilities: 1 Besides the LTM tasks, a TM II may also be responsible for GTL and SM tasks depending on the studies assigned.
For the GTL and SM tasks reference is made to the Job Description for the ED&CP GTL and SM and the GCO Procedural Documents.
2 Collaborates with the FM for performing study feasibility and site assessments, providing recommendation of suitable sites for selection to participate in the trial according to ED&CP decision tree.
Ensures appropriate follow-up of pre-trial visit activities.
Collaborates with the GPL (Global Program Leader), GTL, FM, Site Strategic Lead (SSL), and other study team members to select final sites list.
3 Contributes to the development of study management documents at a country level or initiates development of these documents for trials which follow ED&CP Hybrid Oversight Model.
4 Leads and coordinates local trial team(s) activities in compliance with GCO SOPs, other procedural documents and applicable regulations.
Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget, including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting (if applicable).
5 Ensures that all Serious Adverse Events (SAE)/Product Quality Complaints (PQC)/ Suspected Unexpected Serious Adverse Reactions (SUSAR) are reported within reporting timelines and documented as appropriate.
6 Maintains and updates trial management systems.
Uses study tools and management reports/dashboards available to analyse trial progress.
7 Monitors country and overall study progress (if applicable) and initiates corrective and preventive actions when the trial deviates from plans and communicates study progress and issues to GPL, GTL 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 required.
9 May assist Contract and Compliance Services (CCS) team for negotiation of trial site contracts and budget.
Is responsible or collaborates with Clinical Forecasting & Analytics 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 (either local or multi-country) if applicable and collaborates with SM for site initiation visits.
11 Conducts trial team meetings and provides or facilitates SM training when needed and builds key competencies (i.e., implementation of study amendment-and changes in study related processes).
12 Reviews and approves Visit Reports submitted by SM within procedural timelines; identifies issues and/or trends across a trial/project and escalates deviation/issues to the GTL and FM as needed.
Supports implementation of ARBM (Analytical risk-based monitoring) model as applicable.
13 Supports SM in setting up action plan in case data entry timelines are not respected.
14 Ensures coordination of study supplies at country level or study level as applicable and ensures that clinical drug supplies are appropriately handled, administered and stored in strict adherence with investigational product preparation and administration guidelines in collaboration with SMs, Pharmacy Investigational Product Specialist (PIPS), Site Investigational Product Specialist (SIPS).
15 Monitors site recruitment and sets up an action plan in collaboration with SM in case of non-enrolling sites.
16 Prepares master informed consent and country specific informed consent(s) in accordance with GCO procedural document/templates.
Reviews and manages site specific informed consent forms in accordance with GCO SOPs, other procedural documents and applicable regulations.
17 Organizes IEC/HA approvals, if applicable and ensures that the trial is in compliance with local regulatory requirements.
18 Works with SMs to ensure CAPAs are developed and implemented for audits and inspection or any quality related visits (e.g., On Site Quality Monitoring Visit (OSQMV)) 19 Complies with relevant training requirements.
20 Acts as expert for assigned protocols.
Develops therapeutic area and early development knowledge to support roles and responsibilities.
May represent Global Clinical Operations on cross functional teams.
21 Acts as primary local contact in GCO for a trial.
Establishes and maintains excellent working relationships with external stakeholders, in particular investigators, trial coordinators, other site staff, key contacts in Early Development and/or Clinical Pharmacology and other internal stakeholders.
22 Actively contributes to process improvement initiatives, and training and mentoring of SMs and CTAs.
23 Conducts Accompanied Site Visits with SM as delegated by FM.
24 May assume additional responsibilities or special initiatives such as "Champion" or "Subject Matter Expert".
This is not an exhaustive, comprehensive listing of job functions.
May perform other duties as assigned.
Principal Relationships: Primary Reporting Structure : Reports to Functional Manager (FM).
Primary interfaces: FM, CTAs, SMs, TMs, PIPS, SIPS, GTLs, SSLs, GPLs, Study Responsible Physicians (SRPs), Quality & Compliance Managers/Specialists, Local Safety Officer, Contract and Compliance Services (CCS) Other Internal Interfaces: TA representatives, Medical Affairs, Integrated Data Analytics and Reporting (IDAR), Global Regulatory Affairs, Bioresearch Quality and Compliance (BRQC), Regional Therapeutic Area Expert (RTAE), Clinical Supplies Unit (CSU), ED&CP Head/US ED&CP Head, ED&CP Business Operations & Quality Leader and others as required.
External Interfaces: Investigational Site Staff, Vendor representatives, National Health Authorities and Ethics Committee and others as required.Education and Experience Requirements: § Bachelor's degree or equivalent is required.
A degree in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy) is preferred.
§ Minimum of 8 years of clinical research experience acquired in pharmaceutical industry, CRO or investigational site is required.
ED&CP previous clinical trial experience is preferred.
§ A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
§ Minimum two years of clinical trial management experience (in addition of site monitoring experience) is preferred; however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate's eligibility.
§ Specific therapeutic area experience may be required depending on the position.
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.
§ Willingness to travel with occasional/regular overnight stay away from home depending on the region.
§ Flexible mindset and ability to work at a fast pace within small exploratory international study teams in a fast-changing environment.
§ Ability to work on multiple trials in parallel in different disease areas.