Regional Clinical Trials Operations Lead

hace 3 semanas

Bogota, Colombia Merck Sharp & Dohme A tiempo completo

This role primarily supports in bigger regions (LATAM, Central America and Caribbean) the study portfolio management, focusing in development and strengthening of the regional capabilities in clinical research in assigned Therapeutic Areas (TA).

Under the supervision and oversight of the Regional Operations Head, this role supports the the study allocation strategy, end to end performance and compliance for assigned programs and protocols in the region in compliance with country regulations, Our policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Will collaborate and interact with virtual teams to deliver high performance to meet the strategic and operational goals in the region in accordance with the associated quality standards.

With the Global Operations Lead, the position will coordinate study allocation within the region where recruitment targets can be met, considering country capabilities and business needs.

Will under the supervision of the Regional Operations Head, collaborate actively and broadly across the region with Regional Management and Country Research Directors, with Regional Support Functions to ensure alignment and development of the regional capabilities and can represent the Regional Operations Head if required, can delegate certain key tasks as needed.

**Responsibilities include, but are not limited to**:

- Collaborate closely with regional and global stakeholders to ensure efficient study allocation, based on data analysis as needed.
- Support deliverables on regional objectives, targets and timelines while committing to lead operations in compliance with country regulations, Our policies and procedures, quality standards, and AE reporting requirements internally and externally
- Identify opportunities at a regional level and escalate / align globally
- Collaborate and work closely with other roles country, regional and global stakeholders and Global Clinical Development in order to support development and strengthens the regional capabilities in clinical research
- Supports strategic initiatives across the areas
- Supports regional strategy development consistent with long-term corporate needs in conjunction
- This position impacts directly the regions ability to reach business targets and objectives and ensures that productive collaboration with internal and external business partners are built
- Supports the regional Clinical Trial Allocation oversight in collaboration with relevant support functions
- Collaborate to ensure capacity needs are understood and integrated into Country Allocation discussions
- Participate as required on global initiatives, representing the region. Provide regional input and represent all countries.
- Fosters and acknowledges cultural diversity and cross country business needs in interactions across the region

**Skills**:

- Business and financial acumen
- Strategic thinking
- Ability to think cross-functionally and working across boundaries internationally
- Ability to identify problems, conflicts and opportunities early and lead, analyze mitigation plans and drive conflict resolution is critical
- Sound ICH-GCP knowledge and knowledge of Good Documentation Practices
- Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
- Strong leadership and negotiation skills
- Demonstrated ability to build relationships with senior business executives
- Influencing skills
- Excellent interpersonal and communication skills, conflict management
- Relationship management and networking: strong integration into regional and Headquarters TA network and ability to build productive relationships with all parties
- Effective time management

**Qualification & Experience**:
**Required**:

- Minimum of 10 years in clinical research
- Minimum of 2 years´ experience in a functional management position
- Bachelors degree in Science or equivalent healthcare experience
- Fluent in business proficient in English (verbal and written) and excellent communication skills
- Availability to travel: frequency 40%

**Preferred**:

- CRA, regional project management and CRM experience
- International experience
- Advanced degree, (e.g., MD, PhD, Pharm D, MS)

**Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose

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