Job Summary 
The Senior Clinical Project Manager will use clinical and scientific knowledge as well as leadership and influencing skills to lead, plan, and manage clinical studies in support of the clinical development plan. As a senior clinical project manager, you will work across functional teams to provide project Leadership and Delivery and Lead global clinical team to ensure quality, timelines and budget management. It is a role that requires direct liaise between many functions and the customer, acting as the accountable point for delivery and quality whilst maintaining financial control. This includes the financial performance of assigned projects and for all project deliverables for assigned projects and/or project regions and coordinating activities and deliverables of all project conduct partners and proactively identifies and manages issues.
Duties and Responsibilities:
• Serving as the primary project contact with the client, Leading and managing cross-functional project teams.
• Manages a project as Project Manager overseeing interdisciplinary clinical research programs ensuring compliance with Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs) and regulatory requirements.
• Acts as primary liaison between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement.
• Monitoring team performance against contract and client expectations and according to key performance metrics.
• Leading problem solving including management of risk and issue resolution. Lead creation of risk management plan for assigned studies and propose strategies to mitigate timeline and quality risks.
• Developing or reviewing study management plans.
• Managing team resource assignments and accountability.
• Ensuring compliance with study tools including clinical trial management system and document management system, training materials and standard processes, policies, and procedures. Track study progress with appropriate metrics for recruitment, payments, etc.
• Collaborating and communicating with a variety of colleagues and clients. Communicate study timeline expectations to internal and external study team members.
• Participate in review of project documents, e.g., CRFs (or EDC equivalent), ICFs, recruitment materials, clinical monitoring plans, operation manuals, SOPs, participate in review of protocols, IBs, and clinical sections of NDAs, sNDAs and INDs (including annual reports).
• Assists in the selection, qualification, and management of vendors to support clinical trial execution.
• Develop creative solutions for study recruitment challenges and lead implementation with study sites. Respond to study site questions and escalate internally as appropriate for resolution.
• Assists in pre-study site evaluations as well as new site initiations and trainings and in the development and management of site budgets, timelines, and metrics; ensures completion of study deliverables; provides status update reports.
• Oversee monitoring of study sites and Co-conduct site initiation visits and interim monitoring visits as necessary.
• Lead planning and implementation of investigator meetings.
• Reviews monitoring reports, site audit reports to ensure quality and resolution of site-related issues.
• Ensures tracking and review of protocol deviations and assesses impact on study data.
• Will be expected to provide mentoring in areas of expertise to other team members.
• Participates in bid defense meetings where presented as potential project manager/director. Develops strong relationships with current clients to generate new and/or add-on business for the future.
• Keeps a current awareness of business unit’s and assigned projects’ therapeutic area and drug development trends.
• May train and support new Project Managers. Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training.
Skills and Qualifications:
• Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience.
• Minimum 6 years of relevant experience in the pharmaceutical industry with at least 5 years’ experience in a clinical operations role.
• Experience in the execution of multi-center clinical trials.
• Authorship of clinical documents (ICF templates, clinical monitoring plans, operational plans).
• Experience in leading Phase III and late phase studies, domestic and international.
• Knowledge and understanding of ICH GCP and FDA Code of Federal Regulations.
• Ideally, you will also have some global experience (such as China NMPA and Investigators) and a CRO background.
• Thorough understanding of clinical data management, clinical trial management (including site monitoring), and regulatory compliance.
• Strong interpersonal skills. Ability to influence without authority.
• Good team leadership and Effective mentoring and training skills.
• Excellent customer service skills along with good judgment.
• Good planning and organizational, as well as problem solving skills.
• Effective oral and written communication skills including Presentation skills.
• Ability to effectively interact and communicate with stakeholders, external vendors, and clinical site staff at various management levels.
• Flexibility and willingness to adjust to changing priorities. Ability to work in a fast-paced environment.
• Demonstrated ability to deliver results to the appropriate quality and timeline metrics.
• Proficient in computer applications such as Word, Excel, PowerPoint, and MS Project.
• Willing and able to travel.
• In depth therapeutic and protocol knowledge.
• Ability to work Independently and with a group to set and reach goals.
