Area Study Start Up Lead

hace 3 meses


Ciudad de México CDMX AbbVie A tiempo completo

**Company Description**

Purpose:
The Area SSU Lead is responsible and accountable for on-time, budget and quality delivery and execution of the start-up and maintenance activities of the assigned pipeline and Global Medical Affairs clinical studies within area. The role reports into the Area SSU Head and serves as a single point of accountability across the area for the delivery and execution of the site start up and maintenance activities for the assigned studies within the area. Note:
Area SSU Leads will report into the Area SSU Head but have an operational reporting line to Global SSU Leads. In the US, Area SSU Leads will report in through Area SSU COMs, who report to the Area SSU Head.

Purpose:
The Area SSU Lead is responsible and accountable for on-time, budget and quality delivery and execution of the start-up and maintenance activities of the assigned pipeline and Global Medical Affairs clinical studies within area. The role reports into the Area SSU Head and serves as a single point of accountability across the area for the delivery and execution of the site start up and maintenance activities for the assigned studies within the area. Note:
Area SSU Leads will report into the Area SSU Head but have an operational reporting line to Global SSU Leads. In the US, Area SSU Leads will report in through Area SSU COMs, who report to the Area SSU Head.
**Qualifications**

Qualifications:

- Bachelor degree in health care or scientific field highly preferred, or equivalent years of experience required.
- A minimum of 6 years of clinical
- Research experience and preferably 4+ years of study start up management experience for the designated region.
- Must have hands on experience interpreting regional clinical research regulations and processes. At least 2 years of experience in line management of people, coaching and mentoring
- of staff and teams preferred.
- Preferred exposure in study initiation through study completion in multiple phases of studies (Phase II and III, Phase I in patients). Proven leadership skills in a cross-functional global team environment, experience in working with remote/virtual teams, and an ability to influence and align stakeholders in a cross-functional, multi-cultural environment.
- Strong analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives and drive smart decision making.
- Excellent interpersonal skills with the ability to build trust and
- communicate persuasively and with clarity, flexibility, and adaptability to changing requirements.
- Demonstration of successful program execution, preferably in start up, and aptitude for managing multiple priorities in a fast‐paced environment.
- Demonstration of participation in successful initiatives, special projects, and activities that support the business.
- Advanced working knowledge of ICH and GCP guidelines and operational understanding of the area regulatory environment.

**Additional Information**
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

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