Program Manager, Clinical

Description

Job purpose

The project manager (Clinical) will assist in the planning and execution of clinical development projects from Phase 1 through commercialization with a specialization of clinical operations (Phase 1-3) Pharmacovigilance while adhering to schedule, scope, and budget requirements.

Duties and responsibilities

• The successful candidate will work alongside the clinical operations team helping to translate clinical strategy into detailed project plans. Creating project charts and considering key strategic assumptions from each of the clinical sites and cross-functional dependencies
• Create a monitoring chart for each clinical trial (all the projects) and update those charts on regular basis as agreed with the management team. Chart updates will also be shared with the PMO and Head of clinical regularly
• Analyze, plan, and track project activities on regular basis; proactively identify and resolve operational challenges from different clinical sites and minimize delays that may impact cross-functional teams
• Alliance management of clinical sites
• Track critical path tasks and identify project risks during various stages of clinical operations/development
• Communication of risks to relevant stakeholders
• Work with external CRO or vendor(s) to track project timelines and monitor KPIs
• Coordinate functional project teams and take full accountability of deliverables, balancing quality and timeliness
• Ensure fluid project communication and report project status to project and program leadership
• Implement best practices across project teams e.g., resource capacity planning, project risk management, team performance, timeline development, portfolio management
• Work with functional leaders to ensure positive team spirit and high functioning team
• Prepare monthly progress reports and ad hoc reports as required
• Participates in development of Project Management tools, templates, and processes
• Ability to work outside the typical work hours to accommodate the clinical sites schedule
• Track spending verses budget projections and identify resource needs
• Additional tasks and projects as requested

Qualifications

• Bachelor’s degree in a science discipline or related field is required. M.S. degree desirable
• Minimum 5-8 years of pharmaceutical industry experience, with at least 3-5 years managing clinical projects either directly or through a CRO
• Experience in pharmaceutical drug discovery and development, clinical research/development, or product launch programs
• Knowledge of Good Clinical Practice/ICH guidelines and applicable regulatory and ethical requirements.
• Possesses knowledge of all phases of clinical studies as part of drug development cycle
• Knowledgeable in PM processes and can competently use and employ essential project management tools and methodologies to facilitate project team activities, manage risks and ensure team execution
• PMP certification preferred
• Advanced working knowledge of MS Project, OnePager Pro, Excel, OneNote, and PowerPoint
• High level of personal integrity and strong conflict resolution and consensus building skills
• Ability to work effectively with cross-functional teams
• Ability to travel to the clinical sites based on the requirement

Working conditions

Incumbent will primarily work Monday – Friday during normal business hours in an office environment. Travel up to 10% may be required.

Physical Requirements

This is a largely sedentary role.

Direct reports

None

Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual’s conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.