Senior Project Manager

SUMMARY:

ESSENTIAL DUTIES:

• Reviews study requirements and response assessment criteria, collaborating with key stakeholders to execute study start-up, conduct and close-out activities according to the customer’s and company’s contractual agreements.
• Creates, maintains, and implements definitive project plans (i.e. timelines, milestones and requirements for project staff).
• Establishes and executes project reporting schedules.
• Communicates timely, appropriate project information to project teams, sites, and company/sponsor representative(s).
• Ensures the financial success of the project by forecasting and identifying opportunities to accelerate activities to bring revenue forward
• Determines resources required for project completion and communicating needs to 
• appropriate departmental managers.
• Ensures projects are executed in accordance with Good Clinical Practice (GCP), relevant Standard Operating Procedures (SOPs), and regulatory requirements.
• Coordinates activities and deliverables of all study team members, including training.
• Achieve project quality by identifying quality risks and issues, responding to issues raised by project team and/or sub-team members and planning/implementing appropriate corrective and preventative action plans.
• Manage risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts.
• Provides oversight for study documentation and ensuring project records remain inspection ready.
• Performs financial tasks including monthly billing, forecasting, project scope reviews and amendments, along with pass-through cost management.
• Analyzes project performance for consistency/quality within established project guidelines.
• Hosts regular project meetings with customer(s) to share key updates and current performance.
• Builds positive customer relationships with the goal of acquiring net new awarded projects.
• Identifies lessons learned and implements best practices
• Oversee the full life cycle of regulatory activities from study start-up to study closure and record retention of projects assigned to
• Key stakeholder in Quality Management, Inspection Readiness and supporting audits
• May assist in preparing proposals and budgets
• Coordinates study specific training and other requirements for internal and external staff as appropriate
• Contributes to revisions of Standard Operating Procedures, guidelines and departmental policies
• Support staff development and mentor less experienced project team members on assigned projects to support their professional development
• Performs other duties as required and/or assigned.

QUALIFICATIONS:

• Outstanding interpersonal and client relationship skills with the ability to build and foster positive relationships. 
• Excellent verbal and written communication skills, including the ability to effectively convey ideas and information with clarity. 
• High attention to detail and produces accurate work.
• Strong organization/prioritization skills for the management of multiple concurrent projects with competing deadlines. 
• Capacity to lead and provide direction to others. 
• Ability to work with functional groups and different levels of employees throughout an organization to achieve business results effectively and professionally.
• Proactive and timely follow-up skills: the ability to organize applicable department timelines and follow up with internal and external stakeholder needs as needed.
• Self-motivated; able to work independently to complete tasks respond to department requests and collaborate with others to utilize their resources and knowledge to identify quality solutions.
• Data driven, systems thinker who can generate and execute ideas at strategic and tactical levels. Thrives in a fast-paced environment, integrating disparate activities, new technologies, and agendas while adhering to deadlines and budgets. 
• Strong analytical and problem-solving skills with the ability to understand the big picture. 
• Skilled in interacting and working with others, including peers, patients, management, and internal and external stakeholders.
• Working knowledge of Good Clinical Practice guidelines and Federal research regulations.
• Strong knowledge in clinical trial terminology and practices required.
• Strong computer skills, including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS Office products such as Excel and Word.
• High comprehension of HIPAA privacy and security laws and PHI
• Adaptable in a fast-paced environment with changing priorities, tasks, and client conditions.
• Strong customer service skills with an ability to work under pressure and conflicting client deadlines and requests. 

EDUCATION AND EXPERIENCE:

• BS/BA in Life Science or related discipline.
• 6+ years project management or equivalent experience.
• Minimum 2 years’ experience managing teams, managing projects, and directly or indirectly facilitating workgroups
• Minimum 5 years of experience customer service experience, with at least 5 years of client relationship management experience 
• Over 3 years of financial management experience, including overseeing and managing project level budgets
• Experience executing project plans, timelines, and budgets.
• Experience with clinical trial master filing systems.
• Experience working with or working for local or central IRBs/IBCs 
• Experience in working in hybrid/decentralized trial models is preferred

ENVIRONMENT:

PHYSICAL DEMANDS:

• Regularly work at a desk using a computer for prolonged periods.
• Perform repetitive motion with substantial movements (motions) of the wrists, hands, and/or fingers.
• Regularly communicate via e-mail, telephone, chat, webcam (remote sessions such as MS Teams or Zoom), so others will understand and exchange accurate and timely information.
• Frequently stand/walk, grasp objects, and perform lightly/fine manipulation of objects.
• Occasionally move safely over uneven surfaces.
• Occasionally reach/work above shoulders, twist/bend/stoop/squat, grasp forcefully, lift/carry/push/pull objects that weigh up to 20 pounds.

ADDITIONAL: