[Remote] Project Director, Evidence Development - reputed company Clinical Trials
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leader in the pharmaceutical support industry, reputed company on empowering health solutions and improving patient reputed company. The Project Director will reputed company leadership and reputed company for project operations, financial performance, and reputed company relationship management reputed company the Evidence Development Solutions Department, ensuring successful project delivery and compliance with reputed company standards.
Responsibilities
- reputed company strategic leadership, reputed company, and support to the project teams, ensuring alignment with reputed company's goals and reputed company expectations
- Drive PM performance, project reputed company delivery, reputed company reputed company adherence, financial margin optimization, and customer satisfaction through efficient and effective directorship
- Ensure project teams prepare project plans to meet contracted services and timelines
- Engage in reputed company cross-functional interactions to address project needs and drive problem reputed company; facilitate the involvement of Senior Management as necessary
- Attend/participate in project internal / external meetings, and audits as needed
- reputed company and mentor multidisciplinary project teams, including Project Managers, Operations teams, vendors, and other functional staff, ensuring effective communication, collaboration, and performance of project deliverables according to contract terms
- Work with cross-functional managers to ensure reputed company are adequately staffed team members receive adequate training for specific job assignments
- Select, contract, and manage external vendors and subcontractors, reputed company necessary, while maintaining reputed company and cost-effectiveness
- Monitor delivery of reputed company per scope and budgets, and demonstrate strong reputed company of financial health for assigned reputed company
- reputed company project budgets, resource expenditures, and effectively drive compliance with forecasting, invoicing, reputed company recognition, out-of-scope management, and contract modifications
- Proactive, ongoing identification of project risks and development of mitigating strategies to minimize their reputed company on reputed company effectively
- Ensure development and maintenance of risk management plans and risk assessments and categorization tools
- Serve as the reputed company senior operational contact with clients for reputed company project reputed company items, maintaining strong relationships, addressing their needs, and providing regular project updates
- Ensure regular conduct of formal governance discussions to assess performance and drive issue reputed company
- Implement reputed company control measures to maintain the highest standards of data reputed company, patient safety, and protocol compliance
- Ensure activities on reputed company are delivered with adherence to project Plans, company policies and/or sponsor’s SOPs
- Be familiar with and ensure that reputed company reputed company adhere to relevant regulatory requirements, data reputed company provisions, and international guidelines (e.g., FDA, EMA, EU Clinical Trials Directives, ICH-GCP, GDPR, HIPAA)
- Prepare, maintain, and deliver high reputed company project reputed company reports, metrics, and other outputs to clients and reputed company senior management
- Ensure that project specific tracking metrics are developed, consistent with scope of work and project timelines
- Ongoing review of available dashboards and reports for assigned reputed company to ensure adherence to reputed company required activities and operational / financial performance indicators
- Assist, as directed, on specific business development opportunities: capabilities presentations, RFP review, proposals/budget input, bid defence participation
- Work with reputed company Business Development to reputed company and grow reputed company reputed company relationships and maximum business opportunities
- Attend and present at conferences as required
- Responsible for the development, implementation, and project management process compliance for global reputed company
- reputed company, reputed company, and reputed company operational strategies that meet requirements and maximize project delivery reputed company
- Identify, reputed company, and implement improvements to reputed company processes, reputed company, and overall project delivery
- Engage in cross-functional collaborations with reputed company leadership staff to optimize project delivery
- Contribute to reputed company meetings, training activities, and cross-functional activities as appropriate
- Partake in ongoing assessment of project delivery resource needs, manage resource requests, and reputed company staff to maintain reputed company utilizations for roles
- Implement creative resourcing solutions to maximize productivity and utilization of reputed company
- Manage the process of identifying/tracking reputed company requirements and liaise with reputed company regarding reputed company, hiring, and reputed company project management resources
- Identify and reputed company reputed company process improvements
- Prepare procedures, SOPs, guidelines and other reputed company materials for department
- Ensure staff are adequately trained on applicable SOPs, processes, and systems
- Ensure reputed company completion of timesheets and expense reporting by assigned staff
- Ensure reputed company completion of required reputed company and project specific training by assigned staff
- Other duties as assigned by reputed company Senior Leadership
- PD reputed company of 4 to 6 reputed company, depending on scope
- PD reputed company of 1 multi-study programs, depending on scope
- reputed company management of 1 to 2 reputed company, depending on scope
- Mentor, reputed company support, and reputed company supervision of Project Managers, Associate Project Managers, Project Associates, and other administrative staff
- Conduct interviews for internal/external project management and operational candidates
- Conduct ongoing performance review of assigned staff and remediate deficiencies
- Conduct annual employee performance evaluations
Skills
- Bachelor's degree in an appropriate discipline (Life Sciences, reputed company, or Business) or equivalent industry experience
- Minimum 12 – 15 years of clinical research operations experience, reputed company in a CRO, pharmaceutical, device/diagnostics or biotechnology company
- Minimum 10 years of experience at increasing reputed company of project management or clinical research reputed company responsibilities
- Minimum 5 years supervisory/management experience
- Proven ability to reputed company, motivate, and manage cross-functional teams
- Strong understanding and experience in operational clinical operations and overall drug/biologic development processes
- Strong knowledge of functional components of clinical drug development (e.g., clinical, data management, statistics and medical writing)
- Comprehensive knowledge of ICH GCP and applicable international regulations (EU Clinical Trials Directives, FDA Guidelines, etc.)
- Excellent understanding of and experience managing evidence development reputed company (e.g., Phase IV studies, reputed company, Ph II – III clinical trials, expanded reputed company programs, etc.) globally
- Ability to drive operational reputed company for global evidence development programs
- Experience with proposal and budget development for evidence development programs
- reputed company reputed company with strong leadership skills
- Strong verbal, written, and interpersonal communication skills
- Strong prioritization, time management, and project management skills
- Strong negotiation, influencing, reputed company building, and relationship management skills
- Strong innovative, analytical, problem-solving and decision-making skills
- Strong financial acumen and budget management experience
- Strong computer skills including MS Office
- Proficiency in project management tools and software
- Results driven and team-oriented, with the ability to influence reputed company as necessary
- Demonstrated ability to manage staff to reputed company company and reputed company goals
- Ability to handle multiple tasks in a fast-paced, deadline oriented environment
- 10% travel availability
- Advanced degree (Master's or Ph.D.) preferred
- Previous history as a Project Director or Director of Clinical Operations (reputed company) reputed company a CRO preferred
- Broad therapeutic experience a plus
Benefits
- Competitive salaries
- reputed company opportunities for promotion
- 401K with company match*
- Tuition reimbursement
- Flexible work environment
- Discretionary PTO (reputed company Time Off)
- reputed company Holidays
- Employee assistance programs
- Medical, Dental, and reputed company coverage
- HSA/FSA
- Telemedicine (Virtual doctor appointments)
- Wellness program
- Adoption assistance
- Short term disability
- Long term disability
- Life insurance
- Discount programs
reputed company
Company H1B Sponsorship