Overview:
As a Senior Clinical Study Lead, you will be a key player in one of the most extensive and innovative clinical research organizations, driven by healthcare insights.

Key Responsibilities:

Your Role:

Directs the interdisciplinary study team accountable for the execution of clinical studies and serves as the main liaison for oversight and leadership for the designated study.

Offers operational insights during protocol formulation.

Supervises and contributes to the creation of study-specific documentation, which includes but is not limited to: case report forms (CRF), data management plans, monitoring strategies, project-specific training plans, and statistical analysis plans.

Manages the establishment and upkeep of study systems such as Clinical Trial Management Systems (CTMS) and Trial Master Files (TMF).

Ensures adherence to clinical trial registry mandates.
Identifies the study's outsourcing requirements and leads the engagement, contracting, and management of necessary vendors.
Provides insights into the development and management of baseline budgets and timelines.
Conducts risk assessments and formulates risk mitigation strategies at the study level.
Leads feasibility assessments to determine suitable regions and countries for the study.
Oversees site evaluations and selections.
Facilitates the preparation and execution of investigator meetings.
Monitors site activation progress and monitoring visits, addressing any deviations from the plan.

Develops and implements strategies for patient recruitment and retention, taking corrective actions as necessary.

Oversees data entry and query resolution, addressing any discrepancies from established metrics.
Ensures precise budget management and scope adjustments for both internal and external studies.
Supervises and provides input for study drug and clinical supplies forecasting, drug accountability, and reconciliation.

Escalates issues related to study execution, quality, timelines, or budgets to relevant stakeholders and devises appropriate solutions.

Oversees the execution of clinical studies in accordance with planned timelines, deliverables, and budgets.

Ensures data quality through regular reviews of data metrics, protocol deviations, eligibility violations, dosing discrepancies, and potential serious non-compliance by sites.

Ensures alignment and performance of CROs and Third Party Vendors according to the scope of work.

Guarantees clinical project audit and inspection readiness throughout the study lifecycle.
Supports internal audits and external inspections, contributing to corrective action plans as needed.

Manages and oversees study close-out activities, including database lock, vendor contract reconciliation, budget finalization, TMF, and study drug accountability.

Contributes to the writing and review of clinical study reports.
Facilitates and contributes to lessons learned at the study level.
Assigns tasks to Clinical Study Management staff and supports their deliverables.
Participates in cross-functional and departmental process improvement initiatives.
Responsible for identifying innovative strategies for clinical study execution, considering global perspectives and continuous improvement of CTM SOPs.

May undertake unmasked tasks for studies, which may include but are not limited to assisting with unmasked investigational products, managing unmasked trial master files, reviewing unmasked data in electronic data capture systems, addressing IVRS issues, and overseeing unmasked clinical monitoring.

Qualifications:

Ideal Candidate:

Bachelor's degree or its international equivalent, preferably in a clinical, scientific, or health-related field from an accredited institution; a licensed healthcare professional, such as a registered nurse.

Minimum of 5 years of relevant experience.
Proven interpersonal and leadership capabilities.
Ability to comprehend and implement strategic directions for clinical studies.
A data-driven approach to planning, execution, and problem-solving.
Strong communication skills, both verbal and written, along with presentation abilities.
Proactive, self-disciplined, and capable of meeting deadlines while effectively managing time and prioritization.
Ability to influence and negotiate.
Experience in budget management.
Awareness of relevant industry trends.
Capability to build productive teams and collaborations.
Demonstrated experience in vendor management.

Technical proficiency in trial management systems and MS applications, including but not limited to Project, PowerPoint, Word, Excel, IVRS/IWRS, and EDC.

Experience in global clinical trial operations, including protocol development and key study documentation.
Knowledge of ICH/GCP and regulatory guidelines/directives.
Effective project management skills, cross-functional team leadership, and organizational abilities.
Willingness to travel up to 25% of the time.

What Pharmaceutical Research Associates, Inc. Offers:
Our success is rooted in the quality of our workforce. We prioritize cultivating a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, we provide a comprehensive range of benefits.

Our benefits are designed to be competitive within each country and focus on well-being and work-life balance opportunities for you and your family.

Various annual leave entitlements.
A variety of health insurance options tailored to meet you and your family's needs.
Competitive retirement planning options to maximize savings and ensure confidence for the future.

Global Employee Assistance Programme, offering 24-hour access to a worldwide network of specialized professionals dedicated to supporting your and your family's well-being.

Life assurance.

Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers website to learn more about the benefits of working at

Pharmaceutical Research Associates, Inc.:
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At Pharmaceutical Research Associates, Inc., diversity, inclusion, and belonging are integral to our culture and values. Our rich diversity fosters innovation, enabling us to better serve our people, patients, customers, and communities. We take pride in our diverse workforce and our efforts to become a more inclusive organization. We are committed to providing an inclusive and accessible environment for all candidates. We uphold a workplace free of discrimination and harassment.

All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

If you require reasonable accommodation due to a medical condition or disability for any part of the application process or to perform essential job functions, please inform us through the appropriate channels.

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Interested in the role but unsure if you meet all the requirements? We encourage you to apply regardless – you may be exactly what we are looking for at Pharmaceutical Research Associates, Inc., whether for this position or others.

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