Sr. Trial Manager Early Development

hace 3 meses

Madrid, España Johnson & Johnson A tiempo completo

Position Summary:
The Sr 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 for assigned studies and for delivering 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.

The Sr. 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 Sr. Trial Manager Early Development may perform 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 Sr. Trial Manager Early Development may perform the Site Manager (SM) tasks as described

in GCO procedural documents for ED&CP studies.

The Sr. Trial Manager Early Development 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 Sr. 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.

2 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.

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 analyze 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 PDL, TDL 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. 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.

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 TDL 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, Manager Pharmacy Investigational Product Specialist (PIPS), Manager Site Investigational Product Specialist (SIPS).

15 Monitors site recruitment and set

  • Sr. Clinical Site Manager

    hace 1 mes

    Madrid, España Engineeringuk A tiempo completo

    .As a Senior Clinical Site Manager, you will be joining the world's largest and most comprehensive clinical research organization, powered by healthcare intelligence.You will be responsible for the planning, initiation, coordination, and management of all monitoring and monitoring-related activities, as well as supervision of all site-related activities to...

  • Sr. Clinical Site Manager

    hace 1 mes

    Madrid, España Icon Strategic Solutions A tiempo completo

    .As a Senior Clinical Site Manager, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.You will be responsible for the planning, initiation, coordination and management of all monitoring and monitoring-related activities as well as supervision of all site-related activities to...

  • Sponsor Dedicated Clinical Trial Manager Ii

    hace 7 meses

    Madrid, España Syneos Health Clinical A tiempo completo

    **Description** **Sponsor Dedicated Clinical Trial Manager II / Sr CTM - Home Based in SPAIN** Experience in the management of **global/multi-country** studies and different types of vendors is required. Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique...

  • Sponsor Dedicated Clinical Trial Manager Ii/ Sr

    hace 7 meses

    Madrid, España Syneos Health Clinical A tiempo completo

    **Description** **Sponsor dedicated Clinical Trial Manager II/ Sr CTM - Home Based in Spain** Experience in the management of **global/multi-country** studies and different types of vendors is required. Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product...

  • Early Asset Medical Manager Breast

    hace 3 meses

    Madrid, España AstraZeneca A tiempo completo

    **Job Description / Capsule** - At AstraZeneca, we are focused on the potential of science to address the unmet needs of patients worldwide. We are committed to areas where we believe we can truly change the course of medicine and bring new ideas to life._ The Early Asset Medical Affairs Manager is a scientifically experienced professional that will lead...

  • Clinical Trial Manager Hematology

    hace 3 semanas

    Madrid, Madrid, España Fortrea A tiempo completo

    Job Overview: Fortrea is a leading global contract research organization (CRO) dedicated to transforming drug and device development. As a Clinical Trial Manager, you will play a pivotal role in the execution and oversight of local operational clinical trial activities.About the Role: We are seeking an experienced Clinical Trial Manager to oversee...

  • Local Trial Manager

    hace 7 meses

    Madrid, España Johnson & Johnson A tiempo completo

    **Position Summary**: The Local Trial Manager II (LTM II) is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. The LTM II is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database...

  • Sponsor Dedicated Clinical Trial Manager Ii/ Sr Ctm

    hace 7 meses

    Madrid, España Syneos Health Clinical A tiempo completo

    **Description** **Sponsor Dedicated Clinical Trial Manager II/ Sr CTM - Home Based in SPAIN** Experience in the management of global/multi-country studies and different types of vendors is required. Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical,...

  • Sponsor Dedicated Clinical Trial Manager Ii/ Sr Ctm

    hace 1 día

    Madrid, España Syneos Health Clinical A tiempo completo

    **Description** **Sponsor Dedicated Clinical Trial Manager II/ Sr CTM - Home Based Spain** Experience in the management of global/multi-country studies is required Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly...

  • Local Trial Manager

    hace 3 meses

    Madrid, España ICON A tiempo completo

    As a Local Trial Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. The LTM is the primary point of contact at a country level for assigned studies. The LTM isresponsible for coordinating and leading the local trial team in order to deliver quality data and trial...

  • Global Trial Manager

    hace 14 horas

    Madrid, España Novo Nordisk A tiempo completo

    . Do you wish to be part of an international clinical trial team as we set out on a journey into new and exciting therapeutic areas and ways of working? Can you help us bring new treatments to patients, faster and smarter, by leading and optimizing trial work within your area of expertise? **The position** As a Global Trial Manager within Rare Disease &...

  • Cdc Trial Manager

    hace 7 meses

    Madrid, España Novo Nordisk A tiempo completo

    CDC Trial Manager **Category**:Clinical Development**Location**:Madrid, Comunidad de Madrid, ES- Are you passionate about Trial Management and would like to be part of the patient’s life change?- Do you want to be part of our Clinical Development Centre (CDC) team integrated by Spain and Portugal?- - We are currently recruiting 2 Clinical Trial Manager...

  • Lkv-51 Sponsor Dedicated Clinical Trial Manager Ii/ Sr Ctm

    hace 1 semana

    Madrid, España Importante Empresa A tiempo completo

    .DescriptionSponsor Dedicated Clinical Trial Manager II/ Sr CTM - Home Based SpainExperience in the management of global/multi-country studies is required.Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our...

  • Clinical Scientist, Early Clinical Development-Oncology/Hematology

    hace 4 semanas

    Madrid, España Be-It Ltd A tiempo completo

    .Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...

  • Senior Local Trial Manager

    hace 6 meses

    Madrid, España Johnson & Johnson A tiempo completo

    **Position Summary**: The Local Trial Manager III (LTM III) is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. The LTM III is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database...

  • Clinical Trial Manager

    hace 7 meses

    Madrid, España AbbVie A tiempo completo

    **Company Description** **Job Description** SMA III** As a Clinical Trial Manager, you will be part of a dynamic, centralized study management team that is responsible for the execution of our global clinical trials and a key member of the study team. The Clinical Trial Manager works as an independent, contributing member of a cross-functional and global...

  • Business Development Sr Manager

    hace 3 meses

    Madrid, España Robert Walters Spain A tiempo completo

    .Desde Robert Walters estamos buscando un Business Development Sr Manager para importante empresa de servicios de asesoría estratégica, desarrollo de negocios y expansión internacional ubicada en Palma de Mallorca.Si eres un excelente gestor de equipos que sabe cómo comunicarse y escuchar eficazmente a los demás, tienes la capacidad de supervisar de...

  • Senior Local Trial Manager

    hace 3 meses

    Madrid, España ICON A tiempo completo

    As a Senior Local Trial Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. The LTM is the primary point of contact at a country level for assigned studies. The LTM isresponsible for coordinating and leading the local trial team in order to deliver quality data and trial...

  • Clinical Trial Manager Ii

    hace 1 mes

    Madrid, España Engineeringuk A tiempo completo

    .As a Local Trial Manager, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.The LTM is the primary point of contact at a country level for assigned studies. The LTM is responsible for coordinating and leading the local trial team in order to deliver quality data and trial...

  • Sr Clinical Trial Manager

    hace 1 día

    Madrid, España Syneos Health Clinical A tiempo completo

    **Sr Clinical Trial Manager - Real World & Late Phase - EMEA Based** **-** **(**22003167**)** **Description** **Senior Clinical Trial Manager - dedicated to RWE and Late Phase studies (EMEA based)** Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which...