OptymEdge - Manager, Ophthalmic Certification Project Management Group

Overview:

OptymEdge - Manager, Ophthalmic Certification Project Management Group

US Remote

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients’ lives and act accordingly. We stive to build a collaborative culture at the intersection of being a performance and people driven company. We’re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

The Manager, Ophthalmic Certification Project Management Group (OCPMG) is critical to the successful conduct of ophthalmic certifications in Biopharmaceutical-sponsored clinical trials, as a matrix leader of a vendor project team. The Manager, OCPMG will be client-facing and serve as the internal lead of the project through the life cycle of the study, ensuring effective project delivery in agreement with contracted project timeline and budget. The Manager, OCPMG directs project delivery by driving team and financial efficiency, work product quality, and is responsible for client satisfaction through strong relationship management. The Manager, OCPMG works closely with the Ophthalmic Certification Project Management leadership to ensure compliance with operational tasks, Standard Operating Procedures (SOPs) and overall ophthalmic certification objectives.

Responsibilities:

Accountable for the training, performance management, and mentoring of assigned Project Managers.

Provides ongoing coaching and feedback to Project Managers, including addressing performance issues, conducting formal performance appraisals, and creating development plans. Escalates performance issues to Director, Ophthalmic Project Management.

Coordinates Project Team Meetings, including the development of meeting agendas and minutes.

Ensures training occurs and evaluates proficiency or additional training needs of Project Management (PM) staff.

Tracks PM utilization with the goal to ensure at least 90% utilization of all staff.

Motivates and develops the team.

Develops and oversees recruitment and retention strategies for the Ophthalmic Certification Project Management Group.

Serves as the primary point of contact for biopharma clients and demonstrates proficiency in knowledge and understanding of client needs.

Ensures that deliverables for the assigned projects are completed according to the contract budget, schedule, and quality standards. Projects will be effectively managed in all areas of performance.

Develops successful working relationships with clients, executive management, and project staff and collaborates to manage project issues, proactively identify and mitigate risks and drive milestone achievement.

Tracks project deliverables against contract. Proactively prepares/presents study metrics to maintain transparency for internal/external stakeholders. Monitors trends and drives changes to the plan as needed; identifies risks to delivery and agrees to mitigation plans with the project team to be presented to the client.

Ensures adherence to quality control expectations and milestone timelines for delivery of contractually required reports and deliverables.

Identifies and manages changes to scope and requests for out-of-scope activities. Collaborates with Business Development, Contracts Department, and executive management to ensure timely execution of contract amendments/change orders. Prospectively manages client expectations.

Supports development of Requests for Proposal (RFPs) for biopharma clients in collaboration with leaders and key subject matter experts (SMEs).

Models and propagates Emmes’ commitment to a culture of quality in all aspects of our deliverables, utilizing a solution-based, science-driven, value-added approach in collaborating with clients.

Supports internal stakeholders on departmental initiatives upon request.

Contributes to the development and maintenance Ophthalmic Certification Project Management SOPs and processes in collaboration with department leads.

Supports the identification and implementation of tools and process integrations that support the efficiency and productivity of the OCPMG. This may include but is not limited to collaboration with internal stakeholders and vendors to support global, OCPMG efficiency and standardization within the department.

Performs other duties as assigned.

Qualifications:

Bachelor’s degree or equivalent experience with a minimum 6 years demonstrating related experience, with 3 years working in a pharmaceutical and/or Clinical Research Organization (CRO) setting. 2 years of related supervisory experience.

Demonstrated experience with MS Office Suite, particularly MS Word.

Time management and decision-making skills.

Attention to detail and the ability to address several assignments simultaneously.

Excellent oral and written communication skills.

Some knowledge of clinical trials in ophthalmology preferred.

Emmes requires all US based Clinical Research Associate new hires to be fully vaccinated before their first day of employment. All new hires may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. Emmes complies with all applicable laws regarding reasonable accommodations or exemptions for religious, medical, or other legally protected reasons.

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

Flexible Approved Time Off

Tuition Reimbursement

401k Retirement Plan

Work From Home Anywhere in the US

Maternal/Paternal Leave

Casual Dress Code & Work Environment

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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

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