Associate Clinical Operations Manager I

5 mesi fa

Roma, Italia MSD A tempo pieno

These roles are accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company’s policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for diverse aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.

**Responsibilities include but will not be limited to the following key activities**:

- Tracking (e.g. essential documents) and reporting (e.g. Safety Reports)
- Ensure collation and distribution of study tools and documents
- Update clinical trial databases (CTMS) and trackers
- Clinical supply & non-clinical supply management, in collaboration with other country roles
- Manage Labeling requirements and coordinate/sign translation change request
- Support to CRA for start up activities and site management as required
- Contribute to Execution and oversight of clinical trial country submissions and approvals for assigned protocols.
- Develops working knowledge of local language materials including local language Informed Consents and translations. May interact with IRB/IEC and Regulatory Authority for assigned protocols.
- Supports country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
- Provide support to local vendors as applicable.
- Support of local regulatory and financial compliance.

**Qualification & Experience**:

- Required: Associate Degree or equivalent Health Care related experience
- Preferred: Bachelor’s degree (or higher)
- 1-2 years of experience in Clinical Research or experience in Finance/Business

**Your profile**
- Excellent verbal and written skills, in local language and English
- Strong coordination and organizational skills
- Basic knowledge of budget and contract negotiation process, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up.
- Ability to propose solutions to local study teams.
- ICH/GCP knowledge appropriate to role. Hands on knowledge of Good Documentation Practices
- Able to work with other experienced clinical research professionals to learn and develop skills to manage protocols independently. Works with high quality and compliance mindset.
- Effective and efficient time management, organizational and interpersonal skills, conflict management and problem-solving skills.
- High sense of accountability and urgency in order to properly prioritize deliverables
- Strong communication and negotiation skills in local language and English.
- Ability to focus on multiple deliverables and protocols simultaneously is essential. Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people.
- Positive & growth mindset, capable of working independently and being self-driven

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
Domestic

**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R277141

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