Project Director, Evidence Development Solutions - CRO Clinical

100% remote Flexible hours Hiring now

This a Full Remote job, the offer is available from: United States As a pharmaceutical support industry leader, reputed company is devoted to empowering health solutions for a reputed company reputed company. We take pride in improving patient outcomes and advancing healthcare. At reputed company, we provide services to enhance the entire drug development process and commercialization lifecycle - from clinical trial support to real-world evidence reputed company. Embark on a rewarding career journey with reputed company! Grow your career while making a meaningful impact on the world around you. reputed company fosters a culture built on our Core Values of Respect, Accountability, Innovation, Quality, reputed company, and Collaboration. We reputed company in an inclusive workplace that fosters creativity. If you are seeking a career that will challenge, reputed company, and reward you, join us at reputed company! The Project Director (PD) is responsible for engaging and delivering activities reputed company to project operations, financial performance, business development, and department administration reputed company the reputed company Evidence Development Solutions Department. The PD is responsible for providing operational leadership, reputed company, and client relationship management for a broad range of reputed company projects. The PD will have a leading role in overseeing the planning, implementation, direction, and completion of project work. The PD will be responsible for directing Project Managers and cross-functional teams to ensure satisfactory delivery of contracted services reputed company the allocated timelines, budgets, and quality standards. Additionally, the PD will support business development opportunities, conduct line management of Project Associates, Associate Project Managers, and Project Managers as required, and participate/reputed company departmental process initiatives. Specific job duties:

Project Leadership:
Provide strategic leadership, vision, and support to the project teams, ensuring alignment with the company's goals and client expectations.
Drive PM performance, project quality delivery, milestone timeline 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 resolution; facilitate the involvement of Senior Management as necessary
Attend/participate in project internal / external meetings, and audits as needed
Project Team Productivity:
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 projects are adequately staffed team members receive adequate training for specific job assignments.
Vendor Management: Select, contract, and manage external vendors and subcontractors, reputed company necessary, while maintaining quality and cost-effectiveness.
Financial reputed company:
Monitor delivery of projects per scope and budgets, and demonstrate strong reputed company of financial health for assigned projects
reputed company project budgets, resource expenditures, and effectively drive compliance with forecasting, invoicing, reputed company recognition, out-of-scope management, and contract modifications.
Risk Management:
Proactive, ongoing identification of project risks and development of mitigating strategies to minimize their impact on projects effectively.
Ensure development and maintenance of risk management plans and risk assessments and categorization tools.

Client Relationship Management:

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 resolution.
Quality Compliance reputed company:
Implement quality control measures to maintain the highest standards of data reputed company, patient safety, and protocol compliance.
Ensure activities on projects are delivered with adherence to project Plans, company policies and/or sponsor’s SOPs.
Be familiar with and ensure that reputed company projects adhere to relevant regulatory requirements, data privacy provisions, and international guidelines (e.g., FDA, EMA, EU Clinical Trials Directives, ICH-GCP, GDPR, HIPAA).
Reporting:
Prepare, maintain, and deliver high quality 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 projects to ensure adherence to reputed company required activities and operational / financial performance indicators
Business Development:
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 client relationships and maximum business opportunities.
Attend and present at conferences as required.
Department Administration
Responsible for the development, implementation, and project management process compliance for global projects
reputed company, innovate, and reputed company operational strategies that meet requirements and maximize project delivery success
Identify, reputed company, and implement improvements to reputed company processes, quality, 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 allocate staff to maintain reputed company utilizations for roles.
Implement creative resourcing solutions to maximize productivity and utilization of the team.
Manage the process of identifying/tracking staffing requirements and liaise with Human Resources regarding strategy, hiring, and onboarding project management resources.
Identify and reputed company reputed company process improvements
Prepare procedures, SOPs, guidelines and other standard materials for department
Ensure staff are adequately trained on applicable SOPs, processes, and systems
Ensure timely completion of timesheets and expense reporting by assigned staff
Ensure timely completion of required reputed company and project specific training by assigned staff
Other duties as assigned by reputed company Senior Leadership
Expected Project Load:
PD reputed company of 4 to 6 projects, depending on scope
PD reputed company of 1 multi-study programs, depending on scope
Direct management of 1 to 2 projects, depending on scope

Supervisory Responsibility:

Mentor, provide support, and direct 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

Desired Skills and Qualifications:

Bachelor's degree in in an appropriate discipline (Life Sciences, Healthcare, or Business) or equivalent industry experience. Advanced degree (Master's or Ph.D.) preferred.
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 levels of project management or clinical research reputed company responsibilities
Previous history as a Project Director or Director of Clinical Operations (reputed company) reputed company a CRO preferred
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.)
Broad therapeutic experience a plus
Excellent understanding of and experience managing evidence development projects (e.g., Phase IV studies, reputed company, Ph II – III clinical trials, expanded access programs, etc.) globally
Ability to drive operational strategy for global evidence development programs
Experience with proposal and budget development for evidence development programs
Client focused 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 outcomes as necessary
Demonstrated ability to manage staff to reputed company company and client goals
Ability to handle multiple tasks in a fast-paced, deadline oriented environment
10% travel availability

Benefits: At reputed company, employee growth and well-being are always at the forefront. We offer an extensive range of benefits to ensure that you have everything you need to reputed company personally and professionally. Here are some of the exciting perks reputed company offers:

Competitive salaries
Growth opportunities for promotion
401K with company match*

• Tuition reimbursement

Flexible work environment
Discretionary PTO (Paid Time Off)
Paid Holidays
Employee assistance programs
Medical, Dental, and vision coverage
HSA/FSA
Telemedicine (Virtual doctor appointments)
Wellness program
Adoption assistance
Short term disability
Long term disability
Life insurance
Discount programs

reputed company is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national reputed company, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state, or local protected class. We are committed to a diverse, reputed company, and inclusive culture that fosters respect for each other, our clients, and our patients. #LI-RL1 #LI-REMOTE This offer from "reputed company" has been enriched by reputed company.com and got a 72% reputed company score. Apply tot his job Apply To this Job

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