Site Activation Specialist

7 days ago

Pretoria, South Africa PPD Full time

**JOB DESCRIPTION**:
PPD, now Thermo Fisher’s clinical research business, is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.
At PPD, we are passionate, deliberate, and driven by our purpose
- to improve health

**Accelerated Enrollment Solutions (AES)** is a business unit of PPD that helps biopharmaceutical companies overcome patient recruitment and research site challenges by optimizing each step in the patient journey to deliver greater speed, certainty, and control to clinical trial delivery.

We are currently looking to recruit a **Site Activation Specialist working from home, in South Africa.**
This role is responsible for driving Regional Country/ Site execution of site start-up activities for studies assigned.
Working closely with the Site Operational team and global Site Activation Manager to ensure countries/ sites are set-up for timely site activations, the Site Activation Specialist implements site operational readiness according to the study and client’s start-up strategy for the assigned study/ countries (EMEA).

**Key roles and responsibilities of a Site Activation Specialist are as follows**
- Coordination of activities with the Site Operations team in alignment with the global Site Start-up strategy and client’s expectations to: Action external and internal requests, provide & collate required information, ensure the start-up instruction are executed and implemented in a timely manner, proactively identify risks on the country/site level and develop mitigation plans
- Implement the Site Activation Readiness across sites for assigned studies
- CTMS data entry, tracking & KPIs evaluation and continuous improvement
- Creating and updating site lists
- Various study trackers required by client
- Providing support/data to Site Activation Manager
- Providing oversight and support for prompt scheduling and tracking of PSVs
- Facilitating successful execution of all deliverables within site start-up
- Central Point of contact for coordination of start-up activities for assigned projects on the local level (countries & sites).
- Oversee and coordinate all start-up milestones and collaborate with the Site Managers/Directors to accomplish the defined goals on time
- Oversee and coordinate site activation for assigned projects according to timelines and quality standards
- Maintain trackers of start-up activities and project needs with support from Site Operations Stakeholders (i.e. PSV dates, vendor procurement/ qualifications, EC/IRB submissions, etc.).
- Maintain routine and professional communication with GPMs, CTMs, and sites throughout the entire process, ensuring the selected sites are validated and maximum contract secured
- Act as a regional/country expert regarding the country-specific regulatory and start-up environments

LI-TK2

**Job Qualification**:**
To be considered for this exciting opportunity you will need the following skills and experience -**
- Ideally degree qualified paired with experience in Clinical Research (Site operations/ Project management) environment
- Previous clinical trial related experience, preferably at a global or regional level
- A strong background in providing coordination support to a team with a strong focus on delivering to commercial targets, along with a focus on quality
- Experience in providing good customer service, through strong customer interaction and effective delivery
- Experience and comfort interacting in a matrix environment across a global organization
- Strong IT and written literacy skills
- Fluent English

**Our 4i Values**:
**Integrity - Innovation - Intensity - Involvement**

**Diversity Statement**:
PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.

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