We seek an experienced candidate for the role of CDS Project Management Director to lead, direct and ensure that the contracted services and expectations of the clinical projects and other responsibilities are carried out

Main responsibilities:

- Ensuring that the contracted services and expectations of clinical projects are carried out by the project team of the company and by the executed contract and the expectations of the Customer
- Working as a functional supervisory head of the CDS; managing a staff of CDS Project Managers and CDS Coordinators on projects that are assigned which may range from single service studies to large full scope CDS projects
- Working as the Global Project Manager or Program Manager as required
- Liaising primarily with customers, functional leads, and Senior Management
- Managing relationships with the Company and its Customers to make sure the projects are managed and the management of clinical trials occur by the contractual agreement between the Customer and the Company
- Ensuring that studies progress in accordance with the internal and Customer Quality Standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations
- Serving as the supervisor for a CDS project management, managing other project managers, and specific studies and programs
- Facilitating the communication between the project teams and the upper management
- Acting as a liaison and a facilitator between the departments of operation within the Company for tasks or issues related to projects
- Assisting in the planning and assigning of resources within the department
- Building the infrastructure within the department to ensure that training and communication occur adequately and on a global basis
- Building and maintaining a global team that would cover all possible time zones wherever the businesses of the company is located, and it should be in line with the CDS growth pattern
- Giving line management responsibilities to staff members
- Participating and directing activities related to the operations of the department staff such as interviewing and selection, professional development, performance management, and counseling and separations of employee for direct and indirect reports
- Approving the courses of action on salary administration, interviewing and selection, termination, professional development, performance appraisals, job description preparation, and employee counseling
- Working with and advising staff on the administrative policies and procedures, technical problems, priorities, and methods
- Managing and mentoring other Project Management staff actively on general team leadership skills, customer management skills, project management skills, internal company processes, and for tasks specific to projects
- Managing the executed contract and financial aspects of projects or programs assigned
- Reviewing and approving budgets and expenses of study, and ensuring all the contractual and budgeting issues related to study are upheld and performed as required
- Assisting in ensuring the timely invoicing of customers
- Reviewing the plans and documents of the project management to ensure their consistency and making sure they conform to the SOPs and Work Instruction (WIs) of the company
- Maintaining and evaluating the progress of the project by maintaining the timelines and other tracking or analysis tools
- Producing and distributing status, resourcing and tracking reports, and also functional area plans to the appropriate team members and senior management
- Networking to acquire new business or continue existing ones
- Supporting the Business Development Department by providing information on the CDS Project Management capabilities of the Company
- Presenting the capabilities of the company, and responsibilities specific to CDS PM at the proposal defense meetings of the Customers
- Working with Business Development and the Proposal or Contract groups to develop proposals for opportunities requested by the customer as required, and working with these teams to develop budgets and work scopes for the final contract
- Representing the Company at professional meetings or seminars
- Developing and refining CDS project management processes within the company
- Performing other duties related to work as assigned
- Developing and reviewing SOPs and WIs related to any area concerning the management of the CDS project
- Developing and refining processes within the Company that would lead to greater efficiencies or competitive advantages over other companies
- Establishing and maintaining a training program for PMs and PSs of CDS
- Traveling of up to 45% might be needed

Requirements:

- A B.A or B.S in life sciences, communications, nursing, or any related field
- Experience of project management in a contract research organization, pharmaceutical, or biotechnology company
- Experience in actively managing clinical research projects across the functional areas of CDS, and previous management, CRO, and specific CDS management experience
- An excellent knowledge of the regulations of the FDA, drug development, and project management procedures
- A practical proficiency with ICH/GCP guidelines
- Exceptional leadership, presentation, documentation, and interpersonal skills, with emphasis on proactive leadership, and a team-oriented approach
- Outstanding computer skills in Word, Excel, PowerPoint, MS Project, email, and the internet
- A flexible individual with the ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment simultaneously