Sr. Manager, Clinical Trial (Ophthalmology)

Job Description

This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations company policies and procedures quality standards and adverse event reporting requirements internally and externally. Provide a key support role to TA-Head / CRD to effectively manage team volume of clinical trials and local/regional or global projects. The Sr. CRM may be responsible for managing a specific study for several countries within a cluster.

Responsibilities include but are not limited to:

Main Point of Contact (POC) for assigned protocols and link between Country Operations and Clinical Trial Team (CTT).

May support TA-Head / CRD with oversight of Therapeutic Area program(s) and strategy alignment as needed.

Responsible for project management of the assigned studies: proactively plans drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection recruitment execution and close-out.

Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations company policies and procedures quality standards and adverse event reporting requirements internally and externally.

• Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA-Manager and/or functional vendor and internal management as needed.
• Performs Quality control visits as required.

Leads local study teams to high performance: trains in the protocol other local roles closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the CTCs CRAs and COMs).

Responsible for creating and executing a local risk management plan for assigned studies.

Ensures compliance with CTMS eTMF and other key systems in assigned studies.

Escalates as needed different challenges and issues to TA-Head/CRD/CCQM and or CTT (as appropriate).

Identifies and shares best practices across clinical trials countries and clusters.

May act as a mentor.

Responsible for collaboration with functional outsourcing vendors investigators and other external partners in assigned studies.

Country POC for programmatically outsourced trials for assigned protocols.

As a customer-facing role this position will build business relationships and represent the company with investigators and medical centers.

Serves local business needs as applicable in his/her country (if delegated can sign contracts and manage budgets).

Supports local and regional strategy development consistent with longterm corporate needs in conjunction with CRD TA-Head and Regional Operations.

Collaborates internally with HQ functions regional and local operations EU Clinical Development Pharmacovigilance and Global Medical Affairs to align on key issues/decisions across the trials. Consult with the commercial department as needed.

Qualifications Skills & Experience

Skills:

Expertise in project and site management. The position requires demonstrated success in implementing project management skills at the program and site levels.

Strong organizational skills with demonstrated success required.

Requires the ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments.

Requires a complete understanding of ICH GCP and global/regional/local regulatory environment.

Strong scientific and clinical research knowledge is required. Including extensive knowledge of the regional and/or country clinical trial landscape.

Deep understanding of our R&D Departments organizational structure and cross-functional roles and responsibilities of its members.

Strong understanding of clinical trial planning management and metrics is essential as well as the ability to focus on multiple deliverables and execute complex protocols simultaneously.

Experience functioning as a key link between Country Operations and Clinical Trial Teams.

Communicates effectively and fosters a collaborative spirit in a remote/virtual environment and across countries cultures and functions.

Ability experience and skills to proactively manage resource allocation processes (and controls) productivity quality and project and/or program delivery.

Oversee TA strategy alignment and consolidate relevant information within specific indications escalating to the TA-H / CRD accordingly.

Proficiency in written and spoken English and local language. The incumbent must be competent and effective in written and verbal communication.

Strategic thinking.

Ability to work efficiently in a remote and virtual environment.

The position requires proven strong project management skills and/or project management certification or relevant training program/close mentoring.

High emotional intelligence.

Ability to focus on multiple deliverables and protocols/projects simultaneously.

Exercise strategic thinking and execute effectively across projects.

Fosters understanding of cultural diversity.

Strong leadership skills that enable and drive alignment with the goals purpose and mission of our R&D Department Global Clinical Development (GCD) and Clinical Operations Team.

Ability to identify problems conflicts and opportunities early and lead analyze and creatively prepare mitigation plans and drive conflict resolution is critical.

Required to negotiate skillfully in tough situations with both internal and external groups; settle differences with minimum disruption. Examples of common problems include:

1) Low patient recruitment.

2) Inadequate staff to meet business needs.

3) Performance or compliance issues.

4) Working with regulatory issues and the broader organization.

5) Resolution of conflictive situations.

Educational/pedagogic diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other stakeholders.

Qualification & Experience:

Required:

10 years of experience in clinical research with demonstrated success and increasing responsibilities of which 5 years consisted of leading projects.

Bachelors Degree in Science (or comparable)

Preferred:

CRA Experience preferred.

Advanced degree (e.g. Masters Degree MD PhD)

Required Skills:

Preferred Skills:

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