Lead Trial Manager Early Development

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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:
1.

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.
2.

Collaborates with the Functional Manager (FM) for performing study feasibility ...