Clinical Research Project Planning & Management Skills Training Course

Module 1: Fundamentals of Clinical Research Project Management

ü  Overview of project management principles applied to clinical research

ü  Key differences between general project management and clinical study execution

ü  The clinical trial lifecycle: Initiation, planning, execution, monitoring, and closeout

ü  Regulatory frameworks (FDA, EMA, ICH-GCP) influencing project scope

ü  Practical Session: Constructing a Clinical Trial Charter and Project Scope Statement

Module 2: Clinical Trial Initiation, Scope Management, and Planning

ü  Protocol feasibility analysis and site selection strategies

ü  Defining Work Breakdown Structure (WBS) for complex clinical studies

ü  Establishing clear trial milestones and deliverables

ü  Ethical approvals, IRB/IEC submissions, and regulatory clearance planning

ü  Practical Session: Developing a Work Breakdown Structure (WBS) for a Phase II/III Clinical Trial

Module 3: Clinical Study Budgeting and Financial Management

ü  Cost estimation techniques for clinical trials: Direct and indirect costs

ü  Site payment structures, subject recruitment costs, and investigator grants

ü  Managing budget variances, change orders, and financial forecasting

ü  Tracking trial expenditures against project milestones

ü  Practical Session: Creating a Comprehensive Clinical Trial Budget and Payment Schedule

Module 4: Schedule Optimization and Resource Allocation in Clinical Trials

ü  Developing realistic study schedules using Gantt charts and Critical Path Method (CPM)

ü  Patient recruitment and retention timeline forecasting

ü  Resource leveling and workload management across study sites

ü  Managing schedule compression: Fast-tracking vs. crashing in clinical trials

ü  Practical Session: Designing a Gantt Chart for Trial Schedule Management and Recruitment Tracking

Module 5: Clinical Quality Management and ICH-GCP Compliance

ü  Principles of Risk-Based Quality Management (RBQM) in clinical trials

ü  Designing effective Quality Management Plans (QMP) and Standard Operating Procedures (SOPs)

ü  Preparing sites and project documentation for regulatory inspections and audits

ü  Corrective and Preventive Action (CAPA) plan development

ü  Practical Session: Performing a Mock Trial Audit and Formulating a CAPA Plan

Module 6: Risk Management and Mitigation in Clinical Operations

ü  Identification of clinical trial risks: Protocol failure, non-compliance, and dropout rates

ü  Qualitative and quantitative risk assessment methodologies

ü  Developing a Risk Management Plan and Risk Register

ü  Monitoring risk triggers and executing contingency plans

ü  Practical Session: Building a Clinical Trial Risk Register and Mitigation Strategy

Module 7: Vendor and Contract Research Organization (CRO) Oversight

ü  Request for Proposal (RFP) development and vendor selection criteria

ü  Negotiating Master Services Agreements (MSAs) and Statements of Work (SOWs)

ü  Governance models and key performance indicators (KPIs) for CRO oversight

ü  Managing third-party vendors (central labs, eCOA/ePRO, IXRS/RTSM)

ü  Practical Session: Evaluating Vendor RFPs and Establishing a CRO Performance Scorecard

Module 8: Team Leadership, Stakeholder Management, and Communication

ü  Leading cross-functional clinical trial teams (CRAs, Data Managers, Statisticians)

ü  Stakeholder mapping and communication planning (Sponsors, PIs, Steering Committees)

ü  Managing conflict and cross-cultural challenges in global clinical trials

ü  Effective status reporting and meeting management

ü  Practical Session: Simulating a Stakeholder Crisis Communication and Resolution Strategy

Module 9: Clinical Trial Monitoring, Data Integrity, and Site Management

ü  Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close-Out Visits (COV)

ü  Risk-Based Monitoring (RBM) and centralized data oversight

ü  Ensuring data integrity in Electronic Data Capture (EDC) systems

ü  Managing protocol deviations and non-compliance issues

ü  Practical Session: Drafting a Risk-Based Site Monitoring Plan (SMP)

Module 10: Study Closeout, Reporting, and Continuous Process Improvement

ü  Operational and financial site closeout procedures

ü  Final clinical study report (CSR) preparation and regulatory archiving

ü  Managing investigational product (IP) reconciliation and destruction

ü  Conducting post-project reviews and capturing "Lessons Learned"

ü  Practical Session: Formulating a Complete Trial Closeout Checklist and Lessons Learned Document

About Our Trainers

Our training courses are facilitated by seasoned industry experts and senior clinical project managers with extensive experience in leading global clinical trials across pharmaceutical, biotechnology, and academic sectors. The trainers possess advanced qualifications in project management (PMP®) and clinical research oversight, bringing a wealth of real-world knowledge, practical insights, and regulatory expertise to the learning environment.

Quality Statement

Phoenix Training Center is committed to providing high-quality, impactful, and up-to-date professional training programs. Our curriculum is continuously reviewed and aligned with current international standards, regulatory mandates, and industry best practices. We ensure an engaging learning experience through modern instructional design, expert facilitation, and comprehensive resource materials.

Tailor-Made Courses

We understand that every organization has unique challenges and opportunities as well as unique training needs. Phoenix Training Center offers tailor-made courses designed to address specific requirements and challenges faced by your team or organization. Whether you need a customized curriculum, a specific duration, or on-site delivery, we can adapt our expertise to provide a training solution that perfectly aligns with your objectives. We can customize this Course to focus on your industry, specific risk profile, or internal stakeholder dynamics. Contact us to discuss how we can create a bespoke training program that maximizes value and impact for your team. For further inquiries, please contact us on Tel: +254720272325 / +254737296202 or Email training@phoenixtrainingcenter.com.

Admission Criteria

ü  Participants should be reasonably proficient in English.

ü  Applicants must live up to Phoenix Center for Policy, Research and Training admission criteria.

Terms and Conditions

ü  Discounts: Organizations sponsoring Four Participants will have the 5th attend Free

ü  What is catered for by the Course Fees: Fees cater for all requirements for the training – Learning materials, Lunches, Teas, Snacks and Certification. All participants will additionally cater for their travel and accommodation expenses, visa application, insurance, and other personal expenses.

ü  Certificate Awarded: Participants are awarded Certificates of Participation at the end of the training.

ü  Course Improvement: The program content shown here is for guidance purposes only. Our continuous course improvement process may lead to changes in topics and course structure.

ü  Approval of Course: Our Programs are NITA Approved. Participating organizations can therefore claim reimbursement on fees paid in accordance with NITA Rules.

Booking for Training

Kindly send an email to the Training Officer on training@phoenixtrainingcenter.com and we will send you a registration form. We advise you to book early to avoid missing a seat to this training. Or call us on +254720272325 / +254737296202

Payment Options

We provide 3 payment options, choose one for your convenience, and kindly make payments a week before the training starts (at least 5 to 7 days before the Training start date) to reserve your seat:

ü  Groups of 5 People and Above – Cheque Payments to: Phoenix Center for Policy, Research and Training Limited should be paid in advance, a week before the training starts.

ü  Invoice: We can send a bill directly to you or your company.

ü  Deposit directly into Bank Account (Account details provided upon request)

Cancellation Policy

ü  Payment for all courses includes a registration fee, which is non-refundable, and equals 15% of the total sum of the course fee.

ü  Participants may cancel attendance 14 days or more prior to the training commencement date.

ü  No refunds will be made 14 days or less before the training commencement date. However, participants who are unable to attend may opt to attend a similar training course at a later date or send a substitute participant provided the participation criteria have been met.

Accommodation and Airport Pick-up

For physical training attendees, we can assist with recommendations for accommodation near the training venue. Airport pick-up services can also be arranged upon request to ensure a smooth arrival. Please inform us of your travel details in advance if you require these services. For reservations contact the Training Officer on Email: training@phoenixtrainingcenter.com or on Tel: +254720272325 / +254737296202.