Senior Study Manager, Clinical Research Operations - Ophthalmology

Merck•Boston, MA

10d•Hybrid

About The Position

This position leads the operational planning and execution of one or more clinical trials or significant aspects thereof. 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.

Requirements

Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH).
Ability to manage multiple competing priorities with good planning, time management and prioritization skills.
Solid understanding of the principals of project planning & project management.
Good analytical skills to drive operational milestones.
Influence opinions and decisions of internal and externalcustomers/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.
Problem solving, prioritization, conflict resolution, and critical thinking skills.
Applying leadership skills to processes, leading meetings, and influencing peers in a matrix environment.
Build team capabilities through proactive coaching.
Strong communication, technical writing, and presentation skills.
Bachelor's Degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical field experience.
OR
Master's Degree +3 year of pharmaceutical, clinical drug development, project management, and/or medical field experience.
OR
PhD/PharmD Degree
Ophthalmology experience required.

Nice To Haves

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.
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.