Clinical Research Manager

This role is primarily accountable for the end-to-end performance and project management for assigned protocols in compliance with country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally. The Clinical Research Manager could be responsible for a particular study for several countries in 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).
- Responsible for project management of the assigned studies: pro-actively 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, our company's 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 CTC, CRAs and COM).
- 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/CQM and or CTT (as appropriate) Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies Collaborates internally with HQ functions and locally with PV, Regulatory and GMA to align on key decisions in his/her studies. GHH to be consulted as needed.
- As a customer-facing role, this position will build business relationships and represent our company with investigators

**Experience Requirements**:

- Bachelor degree in Science
- 5-6 years of experience in clinical research
- Fluent Spanish and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
- Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
- Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
- Knowledge in Project Management and site management.
- Strong organizational skills with demonstrated success required.
- Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight, and supervision of the TA Head /CRD
- Requires strong understanding of local regulatory environment
- Strong scientific and clinical research knowledge is required
- Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
- Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions
- Strategic thinking

**Behavioural Competency Expectations**:
Strong leadership skills that enable and drive alignment with the goals, purpose and mission of our Company's Research Labs, Global Clinical Development (GCD) and GCTO
Ability to identify problems, conflicts and opportunities early and lead, analyze and 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.
- Some examples of common problems include:

- low patient recruitment
- inadequate staff to meet business needs
- performance or compliance issues
- working with regulatory issues and the broader organization
- resolution of conflictive situations
- Educational/pedagogic, diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other external stakeholders

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
No relocation

**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Number of Openings**:
1
**Requisition ID**:R195215