Local Clinical Trial Manager - FSP, Saudi Arabia

Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

The PPD FSP Solution:

PPD's Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customers key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality. We deploy the same top-tier talent in ALL engagement models. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.

Joining within our PPD FSP functional area, allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience.

Discover Impactful Work:

Accountable for achieving the final clinical deliverable (usually clean data from evaluated patients as specified in the study protocol) within the time period specified in the contract with the customer. Interprets data on project issues and makes good business decisions with support from experienced team members or line manager. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. Typically works on projects of low to moderate complexity and as part of a team of CTMs.

A day in the Life:

• Leads the local study team consisting of within-country clinical operations team members, cross-functional experts (medical, regulatory, supply logistics, finance, legal, etc.), vendor staff, and external clinical site staff involved in study preparation and delivery providing both matrix leadership and project management of study activities within the country(ies).

• Serves as the operational point-of-contact between the central study team and within-country(ies) study team. The LDL collaborates closely with local medical and regulatory affairs staff to align local medical and scientific requirements. As required, collaborates with the local and above-country teams for conducting study feasibility and site selection within country(ies). Leads selection of sites within country(ies) and is accountable for local study performance.

• Accountable for within-country delivery of assigned studies to time, budget, and quality expectations as defined in the clinical development plan and study protocol as well as in local/regional regulations, IND/GCP/ICH-guidelines, and procedures. Ensures quality and integrity of clinical studies by taking on appropriate business management monitoring activities.

• Ensures development and maintenance of country study plan and that critical study timelines related to study activities within-country(ies) are accurately forecasted and achieved, including budgets, resource estimates, milestones, timelines, quality and risk planning, and that recruitment targets, patient recruitment cycle times, data, and audit/inspection quality are met. Provides troubleshooting and problem resolution support for within-country study team to ensure productive, efficient study delivery. Ensures necessary supplies are available at sites and manages local supply inventory.

• Accountable for the accuracy of study systems, including completeness of the trial master file, and reporting study delivery progress to study team and key stakeholders and to specify and review in-country study monitoring tracking tools, monitors key risk and performance indicators, and other reports. Review all study databases to ensure 100% accuracy.

• Ensures development of country/site-level r