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Job Function R&D; Operations
Job Sub Function Clinical Trial Support
Job Category Professional
All Job Posting Locations Madrid, Spain
Job Description Lead Trial Manager Early Development Position Summary The Lead Trial Manager Early Development is responsible for the local management of a trial in one or more countries acting as the primary point of contact at a country level and for delivering quality data and trial documents / records that are compliant with assigned clinical protocol, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), Health Care Compliance requirements (HCC) and local regulatory requirements.
The Lead Trial Manager Early Development 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 Lead Trial Manager Early Development performs the Trial Delivery Leader (TDL) tasks as described in GCO procedural documents for Early Development and Clinical Pharmacology (ED&CP;) studies which follow the ED&CP; hybrid oversight model.
The Lead Trial Manager Early Development may perform the Site Manager (SM) tasks as described in GCO procedural documents for ED&CP; studies.
The Lead Trial Manager Early Development actively contributes to process improvement initiatives, training and mentoring of TMs, SMs and Clinical Trial Assistants (CTA). While an Associate Trial Manager Early Development, a Sr. Trial Manager Early Development and a Lead Trial Manager Early Development involve overseeing the local management of clinical trials, an Assoc or a Sr Trial Manager Early Development have a more focused and operational role, while a Lead Trial Manager Early Development has a broader scope of responsibility, more authority and a greater emphasis on strategic planning and leadership being often assigned to multi-center complex protocols and can work across Phase 0 – I studies (including FIH studies) in multiple therapeutic areas as needed to drive business needs.
Principal Responsibilities
Besides the LTM tasks a Lead Trial Manager Early Development may also be responsible for TDL and SM tasks depending on the studies assigned. For the TDL and SM tasks reference is made to the Job Description for the ED&CP; TDL and SM and the GCO Procedural Documents.
Collaborates with the Functional Manager (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 Program Delivery Leader (PDL), TDL, FM, Site Strategy Lead (SSL), and other study team members to create the final list of sites.
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.
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).
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.
Maintains and updates trial management systems. Uses study tools and management reports / dashboards available to analyze trial progress.
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 PDL, TDL and study management teams (e.g., ensures appropriate documentation and follow-up related to protocol issue escalation).
May submit requests for vendor services and may support vendor selection. Reviews and approves site and local vendor invoices as required.
May assist Contract and Compliance Services (CCS) team for negotiation of trial site contracts and budget. He / She 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.
Accountable for set-up and conduct of Investigator Meetings (either local or multi-country) if applicable and collaborates with SM for site initiation visits.
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).
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.
Supports SM in setting up action plan in case data entry timelines are not respected.
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, Manager Pharmacy Investigational Product Specialist (PIPS), Manager Site Investigational Product Specialist (SIPS).
Monitors site recruitment and sets up an action plan in collaboration with SM in case of non-enrolling sites.
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.
Organizes IEC / HA approvals, if applicable and ensures that the trial is in compliance with local regulatory requirements.
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)).
Complies with relevant training requirements.
Acts as expert for assigned protocols. Develops therapeutic area and early development knowledge to support roles and responsibilities. May represent GCO on cross functional teams.
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 ED&CP; and other internal stakeholders.
Actively contributes to process improvement initiatives, and training and mentoring of SMs and CTAs.
Conducts Accompanied Site Visits with SM as delegated by FM.
Assumes additional responsibilities or special initiatives such as “Champion” or “Subject Matter Expert”.
Represents functional area in process initiatives.
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, GPLs, SSLs, Compliance
Managers / Specialists, Local Safety Officer.
Other Internal Interfaces : Contract and Compliance Services (CCS), TDM / TDL, Therapeutic Area study team (e.g., Study Responsible Scientists and / or Study Responsible Physicians), Data Management, Medical Affairs, Integrated Data Analytics and Reporting (IDAR), Global Regulatory Affairs, Bioresearch Quality and Compliance (BRQC), Clinical Supplies Unit (CSU) and others as required.
External Interfaces : investigational site staff, external vendor representatives, National Health Authorities and Ethics Committees and others as required.
Education and Experience Requirements
A minimum of a BA or BS degree in Life Sciences (or equivalent experience) is required.
Minimum of 4 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. Previous clinical trial experience in ED&CP; is preferred.
Experience in mentoring / coaching and providing training to TMs / SMs / CTAs.
Specific therapeutic area experience / knowledge may be required depending on the position. Should have solid understanding of the drug development process including ICH / GCP and local regulatory requirements.
Strong leaderships skills, ability to lead initiatives / small teams. Solid communication. Proficient in speaking and writing the country language and English language. Excellent written and oral communication skills.
Strong IT skills in appropriate software and company systems.
Willingness to travel with occasional / regular overnight stay away from home depending on the region.
Adaptable 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.
Required Skills
Clinical Data Management
Clinical Evaluations
Clinical Research and Regulations
Clinical Trial Protocols
Clinical Trials Operations
Communication
Data Savvy
Empowering People
Issue Escalation
Laboratory Operations
Problem Solving
Program Management
Project Support
Research and Development
Standard Operating Procedure (SOP)
Study Management
Technical Credibility
Preferred Skills
Clinical Data Management
Clinical Evaluations
Clinical Research and Regulations
Clinical Trial Protocols
Clinical Trials Operations
Communication
Data Savvy
Empowering People
Issue Escalation
Laboratory Operations
Problem Solving
Program Management
Project Support
Research and Development
Standard Operating Procedure (SOP)
Study Management
Technical Credibility
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