Sr. Clinical Project Manager
Cellphire Therapeutics is a Rockville, MD-based biotechnology company focused on developing platelet-based products to save lives. Our lead product, Thrombosomes®, is a platelet-based freeze-dried hemostatic. Cellphire’s goal is to revolutionize hemostasis management through the development of the next generation of platelet-based products that will efficiently stop bleeding. We believe that our products will ensure platelet availability to all patients regardless of location or environment.
We are growing! As we grow, we have identified a need for a Senior Clinical Project Manager. You will serve as the primary operational lead for the cross-functional team and contact for the trial. You are responsible for the planning and implementation of one or more clinical trials within a therapeutic area. You will ensure project milestones delivery on time, within the budget, high quality and in compliance with the ICH-GCP, Regulatory guidelines and all applicable SOPs/work instructions. You should be a strong leader and able to mentor junior staff and perform additional duties or functions as required including performance appraisals as applicable.
Daily responsibilities are robust. Below is a sampling of requisite tasks:
- Responsible for all operational aspects and progress of clinical trial from a study planning activities to a study completion including ongoing tracking of all applicable key milestones, performance metrics and quality indicators.
- Develops and maintains the clinical trial deliverables including timeline sand budget
- Serves as an escalation point and resources for internal/eternal teams and investigational sites; partners with cross-functional teams to achieve deliverables.
- Oversees/facilitates with Clinical Development a country and site feasibility/selection process and documentation, subject recruitment and retention strategy and related activities
- Provides operations and strategy input and /or approves study documents subject a protocol synopsis, Informed consent, eCRFs, CRF completion Guidelines, Study Plans and Manuals, and Clinical Study Reports development.
- Responsible for management of Clinical Trial Team (CTT) meetings and other internal meetings as required
- Responsible for oversight of all vendors including data management and clinical operations activities in review of clinical data, provides guidance on issues and queries as needed and implements risk management work process and documentation, as appropriate
- Responsible for and participates in clinical service provider selection and development of scope of work, budget, and establishing the project timelines as a part of outsourcing activities.
- Provides oversight for all vendor operations activities (e.g. study management, monitoring, specifications development, UATs, issues escalations)
- Responsible for the selection and oversight of a study specific and GCP training of CRO study staff assigned for the trials conduct, investigational sites and vendors
- Manages CRO/vendor contract agreements, ensuring the change orders and budgets meet clinical operations specifications including review and approval of study invoices and ensuring their accuracy according to the contract and work performed by the CRO/vendor
- Oversee/responsible for the eTMF set up ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packages
- Ensure that all aspects of GCP compliance and audit readiness are maintained thought out trial conduct
- Conduct sponsor quality monitoring/oversight sites to sites
- Creates, manages, measures and reports timelines for milestone deliverables
- Proactively manages/identifies potential study issues/risks and recommends solution with key internal or external stake holders
- Prepares metric and updates for the management
- Oversees internal team meetings, investigator meetings and other trial specific meetings
- Participation in development, review and implement departmental SOPs, WIs and other work process improvement initiatives
- Responsible for the reconciliation of budget for the studies with strong understanding of budget management and cost drivers
- Collaborates in the development and management of vendor scope of work (SOW) per contract, quality, budget and other detailed timelines
- Reviews and approves vendor invoices, provides oversight of CRO in management of site payments
- Participation in the development of creative solutions in management of clinical trial, updates and/or development of working instructions and SOPs, document management, clinical operations personnel training development and conduct, and review/updates as needed in quality control processes.
- Contributes to wider organizational goals and or activities as assigned
- Maintains completion of required corporate training on standards, policies, work instruction buy due date
- Mentors clinical operations personnel in clinical trial execution
- Supports the Clinical Operations Management and team by performing other tasks as needed
- May have up to 3 direct reports
- BS in scientific discipline or RN license. Advanced degree (MA/MS/PharmD, PhD) preferred
- Minimum 5 years progressive experience in clinical trial execution in industry setting ( CRO or sponsor) with minimum 1+ years experience of line management
- At minimum 3+years experience in management of CROs and other external vendors
- Strong working knowledge of drug development process (biologics are desired)
- Basic understanding of FDA regulations and the biologics development process desired and electronic submission requirements (eCTD).
- Detailed knowledge of advanced concepts of Good Clinical Practice and regulatory requirements.
- Understand line management function
- Global trial execution and experience with various health and ethics agencies
- Must be well experienced with Microsoft Project, and Microsoft Office Suite Products including MS Word, Excel, and PowerPoint. SharePoint and Visio experience is desirable but not required.
- Able to read, analyze, and interpret information from professional journals, technical procedures, or governmental regulations.
- Excellent written and verbal communication skills
- Experience working on hemostasis trials prefer but not required
- Must be able to travel up to 25% of the time
- Able to prioritize and handle multiple tasks
- Ability to function in a fast pace, dynamic environment and dealing with ambiguity
- Must display problem-solving skills
- Must be a self-starter and team player with strong interpersonal skills
The candidate must be willing to work in a fast-paced biotechnology environment and to work a flexible schedule on short notice. Late-night and weekend work will be required occasionally but not routinely.
What Else You Should Know
At Cellphire, we care about our employees' physical and financial welfare. Our current benefits package includes:
- 100% paid Medical, Dental, and Vision insurance
- Flexible Spending Accounts
- Life and Disability Insurance
- Paid Time Off, Plus Holidays
- 401(k) Match
- Stock Options
- Tuition Assistance
Sound interesting? Take the next step and submit your credentials – a resume and a cover email today. Join us and be part of a company that is making a difference and saving lives.
Cellphire is committed to providing equal employment opportunities to all employees and applicants without regard to race, ethnicity, religion, color, sex (including childbirth, breast feeding and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age, protected medical condition, genetic information, disability or any other protected status in accordance with all applicable federal, state, and local laws.