Description:

Provide operational oversight of, and expertise to, cross-functional project teams, that will include task/functional managers who oversee the day-to-day operation for other functional areas.

Plan and manage day-to-day operational aspects of one or more assigned programs/projects or tasks, including the following, as required: planning/timelines, budgeting, resourcing, and vendor management/interfacing. Identify and proactively work to remove obstacles, mitigate risks, and escalates issues; both internally and to the client (Contracting Officers Representative (COR), or designee(s)), as needed.

Interface with clients and program/project staff; ensure provision of meeting agendas and summary documentation, as well as detailed information required for internal and client meetings.

Prepare and/or review full or sections for monthly, quarterly, and annual reports; may present at internal and/or scientific meetings.

Ensure documentation of processes and workflows are being followed and occurring within projected timelines and determine course of action to prevent and remediate delays. Identify gaps and propose solutions to improve efficiency and quality of deliverables. Maintain a high level of accuracy and attention to detail in a fast-paced environment with shifting priorities.

Carry out numerous and varied activities associated with the conduct and successful performance of clinical trials/studies with demonstrated expertise and ability to navigate in at least one project/contract-specific tool or system in support of the following: patient recruitment; data management, collection and processing of adverse events reports; tracking and reporting of site monitoring/management activities, and/or regulatory document collection (e.g., EDC, CTMS, or eTMF systems).

Represent clinical-trial related operations at study team meetings, participate in collaborative efforts and play an important cross-functional role.

Perform duties within established SOPs and in accordance with Good Clinical Practice (GCP). Ensure project quality and compliance with FDA regulations and ICH (R2) guideline, and with NIH policies or other sponsor-specific requirements.

Provide oversight and mentorship to staff in the delivery of quality work and performance metrics, as per task order and/or project deliverables.

Expect to include line management responsibility and staff hiring activities.

Support and comply with the company's Quality Management System policies and procedures. Drives innovative project and company performance improvement solutions, including corrective and preventive (CAPA) actions, as needed. Perform risk-based quality content reviews and monitor internal/external KPIs, as required by the client.

Contributes to Corporate Initiatives, e.g., SOP development and proposals for government and commercial clients.

Job Requirements

Working knowledge and application of FDA/EMA and other regulatory requirements, i.e., GCPs/ICH (R2) guidelines to include domestic and global regulatory requirements.

Broad multidisciplinary understanding of the pharmaceutical clinical research and development processes with hands on regulatory, clinical operations, or clinical trial monitoring/management experience, e.g., clinical study design, conduct, management, reporting, and/or product development life cycle.

Demonstrated ability to take a leadership role and drive quality progress.

Display excellent organizational skills and exhibit professionalism and integrity.

Demonstrated project and client management skills.

Strong presentation, problem-solving, and conflict resolution skills.

Seasoned oral and written communication skills.

Expertise in Microsoft Word, PowerPoint, and Excel is required, and experience with Microsoft Project.

Experience in Infectious Disease/HIV clinical trials and/or Oncology preferred; prior work on a government contract, is a plus.

Additional Skills & Qualifications:

Driven

Propose new ideas

Identify gaps

ability to manage multiple trials at a time

Next Gen Sequencing for preventative Covid trials

Proposals

SSU

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.