Senior Study Manager, Immunology

Merck; North Wales (Montgomery County); On-site; USD 120,000 - 160,000; Full time

Job summary

Merck is seeking a Clinical Trial Operations Lead to drive planning and execution of one or more trials within the Tulisokibart program. You will collaborate with a global cross-functional team and apply project management, communication, and leadership skills to support trial objectives.

The role involves leading timeline management, risk mitigation, stakeholder collaboration, and vendor management to ensure study milestones are met and regulatory requirements are satisfied.

Qualifications

• ,Bachelor's degree or higher with 5+ years in pharma/clinical drug development or PM.
• Master's degree with 3+ years in similar fields.
• PhD/PharmD considered.
• Degree in life sciences preferred.

Responsibilities

• Responsible for the operational planning, feasibility, and execution of a clinical trial
• May serve as the clinical trial team lead
• Lead team in 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, 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 in support of clinical study objectives
• Accountable for managing any study specific partners and/or vendors

Skills

Project management

GCP/ICH knowledge

Time management

Project planning

Analytical skills

Leadership in matrix

Communication skills

Problem solving

MS Office

Education

Bachelor's Degree in life sciences

Master's Degree in life sciences or related field

PhD/PharmD

Life sciences degree preferred

Job description

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