Senior Study Manager, Immunology

Merck; San Diego (CA); Sur place; USD 110 000 - 150 000; Plein temps

Résumé du poste

Merck in San Diego seeks an experienced Clinical Trials Program Lead to drive operational planning and execution of one or more trials in our portfolio. You will lead cross-functional teams, apply project management, regulatory knowledge (GCP/ICH), and strengthen collaboration with country sites and vendors.

The role focuses on timeline management, risk mitigation, and study-wide communications, including data management deliverables, site materials, and status reports.

Qualifications

• Bachelor's Degree with 5+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience.
• Master's Degree with 3+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience.
• PhD/PharmD Degree in life sciences is acceptable.
• Degree in life sciences, preferred.

Responsabilités

• Operational planning, feasibility, and execution of a clinical trial.
• May serve as the clinical trial team lead.
• Lead study planning, development, and execution elements (data management deliverables, trial level plans/timelines, country/site selection, site materials, system updates, investigator meeting planning, communication plans, status update reports, study close out activities).
• Leads team for timeline management, risk identification and mitigation, issue resolution.
• Facilitate and collaborate with internal/external stakeholders (study team, country teams, vendors, committees) in support of clinical study objectives.
• Accountable for managing any study specific partners and/or vendors.

Connaissances

Operational planning

Clinical trial management

GCP/ICH knowledge

Multi-tasking & prioritization

Project planning

Analytical skills

Stakeholder management

Communication skills

MS Office proficiency

Formation

Bachelor's Degree + 5+ years

Master's Degree + 3+ years

PhD/PharmD Degree

Life sciences degree preferred

Description du poste

Job Description

This position leads the operational planning and execution of one or more clinical trials or significant aspects thereof in our Tulisokibart program. In this position, you will have the opportunity to demonstrate your leadership and technical skills as part of a global, cross-functional team. You will apply project management, communication, and collaboration skills in support of our clinical trials.

• Responsible for the operational planning, feasibility, and execution of a clinical trial
• May serve as the clinical trial team lead
• May lead team in key study planning, development, and execution elements (e.g., data management deliverables, trial level plans/timelines, country/site selection, site materials, system updates, investigator meeting planning, communication plans, preparation of status update reports, study close out activities)
• Leads team for timeline management, risk identification and mitigation, issue resolution
• May facilitate and collaborate with key internal/external stakeholders (e.g., study team, country teams, vendors, committees) in support of clinical study objectives
• Accountable for managing any study specific partners and/or vendors

Job Description

This position leads the operational planning and execution of one or more clinical trials or significant aspects thereof in our Tulisokibart program. In this position, you will have the opportunity to demonstrate your leadership and technical skills as part of a global, cross-functional team. You will apply project management, communication, and collaboration skills in support of our clinical trials.

• Responsible for the operational planning, feasibility, and execution of a clinical trial
• May serve as the clinical trial team lead
• May lead team in key study planning, development, and execution elements (e.g., data management deliverables, trial level plans/timelines, country/site selection, site materials, system updates, investigator meeting planning, communication plans, preparation of status update reports, study close out activities)
• Leads team for timeline management, risk identification and mitigation, issue resolution
• May facilitate and collaborate with key internal/external stakeholders (e.g., study team, country teams, vendors, committees) in support of clinical study objectives
• Accountable for managing any study specific partners and/or vendors

Job Responsibilities

• Responsible for the operational planning, feasibility, and execution of a clinical trial
• May serve as the clinical trial team lead
• May lead team in key study planning, development, and execution elements (e.g., data management deliverables, trial level plans/timelines, country/site selection, site materials, system updates, investigator meeting planning, communication plans, preparation of status update reports, study close out activities)
• Leads team for timeline management, risk identification and mitigation, issue resolution
• May facilitate and collaborate with key internal/external stakeholders (e.g., study team, country teams, vendors, committees) in support of clinical study objectives
• Accountable for managing any study specific partners and/or vendors

Core Skills

• Demonstrated ability to drive and manage operational activities on clinical protocols. This position may represent the company through external partnerships, collaborations, and key strategic engagements. This includes the ability to:
• Solid knowledge of clinical research regulatory requirements (e.g., Good Clinical Practice (GCP) and International Council for Harmonisation (ICH))
• Ability to manage multiple competing priorities with good planning, time management and prioritization skills
• Solid understanding of the principles of project planning & project management
• Good analytical skills to drive operational milestones
• Influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the division
• Interact with key stakeholders across department, division, and company. Role requires a proactive approach and leadership driving toward study goals
• Applying leadership skills to processes, leading meetings, and influencing peers in a matrix environment
• Problem solving, prioritization, conflict resolution, and critical thinking skills
• Strong communication, writing, and presentation skills
• Intermediate knowledge in Microsoft office or similar (Excel, PowerPoint, Word, Outlook, etc.)

Education/Experience

• Bachelor's Degree and 5+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience -OR-
• Master's Degree and 3+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience -OR-
• PhD/PharmD Degree
• Degree in life sciences, preferred