Senior Clinical Project Manager (Remote)

The Senior Project Manager (SPM) fulfills the requirements of managing clinical trials (typically multi-center, multi-national projects) to ensure timely delivery of project required objectives and timelines within the scope of the client agreements for assigned projects and the project budget, with quality. In doing so, the SPM is responsible for the cross-functional team's compliance with the project Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines, and other applicable regulations. The SPM is responsible for the overall execution of the project and maybe principal liaison with the client to ensure effective and timely communication of project progress, issues, and plans for resolution of those issues.

Project Responsibilities:

Develops clear and measurable project management plan in conjunction with Client representative(s) and internal stakeholders.

Global management of clinical projects/programs, including deliverables from all functional areas and vendors in accordance with contractual timelines, client specifications, quality, and GCP.

Establishes project metrics and project report schedules with client representatives. Provides at least monthly project updates.

Act as the primary liaison between the project team and the client/customers and service providers.

Identifies critical project success factors for tracking, analysis, and reporting including probability, impact, and mitigation of project risks.

Manages adherence to project budget and contracts.

Manages adherence to project timelines and develops creative solutions to ensure on-time delivery as needed.

Monitors project status, budget expenditures, and identifies problems, and proactively recommends solutions.

Coordinates assignment of needed resources for project conduct and completion with functional area leaders; ensures appropriate staffing to accomplish project goals within budget.

Develops budget and expense review strategy; creates scope definition documents and creates proactive cost containment strategies and communicates with project team; regularly reviews budget/expenses with the project team.

Identifies out of scope work and initiates the scope change process with client representatives and internal stakeholders.

Ensures the site contract and budget negotiation process is completed in accordance with project timelines and cost parameters.

Responsible for review and approval of project grants, expense reports, and financial records (invoicing/units/expenses) in conjunction with appropriate project team members.

Accountable for the development, oversight, and delivery of project team training.

Determines needed project processes, trains, and maintains project team knowledge/application of project processes.

Establishes and communicates team performance expectations and guidelines.

Manages performance of all service providers, delegating appropriate and challenging assignments to encourage growth, development, and responsibility.

Review and refine project processes and take responsibility for identifying new approaches/systems to improve efficiency and delivery of client work.

Organization/Departmental Responsibilities:

Provides performance evaluation input for Caidya project team members and service providers.

Assists in the development and mentoring of new and junior members of the Project Management Department.

Reviews and complies with Caidya Standard Operating Procedures (SOPs)

May participate in development and review of departmental Standard Operating Procedures (SOPs), guidelines, and intradepartmental procedures, and other continuous process improvements programs, as assigned.

Business Development Responsibilities:

Collaborates with assigned Caidya team members in the preparation of bid defense materials and presentation of project management capabilities at bid defenses.

Represents Caidya Project Management at professional, marketing, and new business meetings.

Supervisory Responsibilities:

No supervisory responsibilities.

Job Requirements:

Education:

Bachelor's degree preferred; PMP certification/advanced degree or equivalent clinical research experience a plus.

Experience :

3 years of clinical project management experience with at least 2 years of multi-national experience, or equivalent combination of education, training, and experience in the clinical research industry.

7+ years of strong clinical research background, including medical and/or scientific experience is preferred.

Skills/Competencies:

Expertise in project management - Mature management skills demonstrated by a calm and thorough review of situations. Proactively identifies and or addresses problems. Seeks to understand all contributing factors and subsequent implications. Proposes, implements, and evaluates appropriate solutions. Highly self-motivated and proactive with the ability to work independently. Sound judgment and decision-making skills. Exceptional attention to detail and ability to work simultaneously on multiple priorities. Flexible personality and a quick learner who operates with a sense of urgency.

Ability to manage projects in culturally diverse settings - demonstrated knowledge of different cultural sensitivities within regions and/or countries that could impact the progress of a clinical trial(s), and an ability to use that knowledge to manage relationships and to share that knowledge with the larger project team.

Strong leadership skills - Aligns goals for self, team and department with the goals of Caidya. Builds and develops unified teams that take action to achieve goals. Shows flexibility and ability to persevere as objectives change.

Client management skills - proven ability to manage client expectations, work creatively to solve challenges and consistently deliver a proactive, solution-oriented approach to client management.

Knowledge of field organizational strategies - The ability to adapt to a rapidly changing work environment, demonstrating flexibility and capacity to manage competing and changing priorities. Successful decentralized team management and situational responsive decision-making.

Develops new and existing employees (mentoring, listening, and evaluation skills) - Develops and supports others to grow within a positive learning environment. Ability to coach/mentor junior members of the project team.

Extensive knowledge of clinical research - Thoroughly understands the drug development process. Knowledgeable about the critical elements for success in clinical trials; participation in and contribution to these activities. Ability to review protocols, programs, and assess the success of a project. Competent at identifying risks and implementing successful mitigation strategies.

Financial Management - Strong understanding of financial management (time and cost, forecasting, revenue recognition, margins, invoicing, and utilization).

Strong communication and presentation skills - Demonstrates strong written and verbal communication skills and excellent interpersonal skills. Ability to establish and maintain positive Client, project team member, and internal Caidya relationships. Ability to conduct effective, engaging, and persuasive presentations.

Computer skills - Working knowledge of MS Office suite and MS Project or equivalent. Able to generate business correspondence, create forms and generate reports as required.

Practices professionalism and integrity in all actions - Demonstrated ability to foster concepts of teamwork, cooperation, self-control, and flexibility to get the work done.

Capabilities :

Ability to communicate in English (both verbal and written).

Travel, as needed, for project team meetings, client presentations and other professional meetings/conferences.