Senior Clinical Project Manager/Clinical Project Manager (Remote)

Glycomine is a small clinical stage bio tech company committed to developing therapeutics for  congenital disorders of glycosylation (CDG), serious rare diseases for which the vast majority of which do not have any disease-modifying treatment options available. Many of these diseases are driven by a genetic mutation that disrupts the function of an important enzyme. Glycomine’s lead clinical program in PMM2-CDG aims to deliver a substrate to bypass the enzymatic problem. 

Our team has a special dedication to find solutions to the significant unmet medical need experienced by patients and families with rare diseases. We come from many disciplines and bring multiple viewpoints and broad expertise to our mission. We are driven by the imperative and the opportunity to develop therapies that can provide meaningful improvements in the quality of life for patients, caregivers, and families.

The Senior Clinical Project Manager/Clinical Project Manager is a team-player role responsible for supporting aspects of clinical operations for our programs. This individual possesses clinical operations expertise with a track record of success, working with peers and stakeholders across multiple disciplines to drive a key program with multiple studies and indications through all phases of clinical trials (Phase I-III). The Senior Clinical Project Manager/Clinical Project Manager is a role in the Clinical Development organization who knows how to work closely with vendors and clinical sites.

As a Senior Clinical Project Manager/Clinical Project Manager at Glycomine, you will play a pivotal role in driving the success of critical clinical programs. You'll provide support and experience to the program and members of our Clinical Development team to ensure the seamless execution of clinical trials. In this role, you'll collaborate across diverse functions, support key initiatives, and promote timely, on-budget trial completion that adheres to the highest quality standards.

You will be a member of a team that is responsible for the planning, implementation, execution, and management of clinical studies by overseeing day-to-day operations and directly managing and working with outside Clinical Research Organizations (CROs), clinical sites and their teams, and third-party vendors. You will thrive in a fast-paced, innovative environment, while remaining flexible, proactive, resourceful, and efficient. The ability to analyze complex issues to quickly develop relevant and realistic plans and recommendations for implementation is essential. Also necessary are excellent matrix management skills, written and verbal communication skills, attention to detail, and knowledge of quality obligations.

This is a remote based position ideally located in east coast time zone.

Responsibilities include, but are not limited to the following:

• Prepare or review site feasibility reports and support the study team in site selection.
• Ensure efficient and through study start-up, by overseeing the CRO and vendors and working closely with relevant team members involved in study set up (CMC, Reg, etc). Ensure timeline collection of all start-up documents (example ethics documents for submission), site Clinical Trial Agreements and start up activities are performed prior to each site activation.
• Work closely with the Director of Clinical Operations to review the study timelines and milestones are being met.
• Manage the scope of work, change notifications, contract modification, site trial agreements, and other necessary budgetary information for clinical trial operations
• Review site visits per Oversight Plan and conduct study oversights as needed.
• Be responsible for oversight activities of vendors (example CRO, lab vendors, etc)
• Assist in the preparation and implementation of study plans (example Monitoring Plan, Oversight Plan, etc).
• Collaborate cross functionally with internal teams, including Clinical Development, Regulatory Affairs, Translational Medicine and Program Leadership to ensure alignment on clinical trial objectives and milestones
• Serve as a point of contact for CROs and vendors, overseeing their performance and ensuring adherence to contractual agreements, timelines and quality standards
• Ensure compliance with regulatory requirements, ICH-GCP requirements, and company SOPs throughout all stages of clinical trial conduct
• Oversee the collection, analysis and interpretation of clinical trial data, working closely with Clinical Development, Biostatistics and Data Management teams to ensure data accuracy and integrity
• Contribute, if needed, to the preparation and review of clinical study documents including the Investigator Brochure, Investigational New Drug Applications (IND), study protocols, clinical study reports, applicable sections of New Drug Applications (NDA) and or Marketing Authorization Application (MAA), updates to the IND, NDA and other safety reports.
• Forge strong relationships with investigators, site staff, and CROs, effectively communicating study concepts while overseeing operational strategies for achieving program goals.
•  Contribute in review of operational risk management strategies
•  Part of the team who oversee the timely capture, reporting, and evaluation of adverse events and product safety issues.
• Oversee clinical and regulatory files, including the essential Trial Master File (TMF).
• Work cross-functionally to support the relevant and timely exchange of information and materials to support clinical trial deliverables
• Be part of the team that manages clinical trials from start-up through close-out to ensure that both internal and external deliverables are on time and on budget while collaborating across functional areas
• Proactively manage clinical trial outsourced partners, including identification of risk, to ensure trial deliverables and performance goals are met
• Maintain partnerships through positive relationships with CRO counterparts; proactively review and identify potential issues or problems with the sites and communicate/escalate to clinical leadership
• Collaborate with CROs to keep the clinical study database current, accurate, and routinely cleaned
• Support and manage oversight activities of all necessary vendors to ensure a high level of operational excellence is maintained

Qualifications:

• BA/BS preferably in a health-related field; preferred MA/MS degree in biological, life science, nursing or related field but not required.
• At least 5 years of experience in clinical operations within the pharmaceutical or biotechnology industry.
• Strong experience in managing and developing relationships with contract research organizations (CROs).
• Demonstrated excellence in managing clinical trials and a solid understanding of the trial processes.
• Proven track record of success and a history of innovative program and trial execution to ensure study progress, timelines, data integrity, and compliance with health authority requirements.
• Domain expertise in drug development, with a preference for experience in early-stage clinical trials.
• Strong vendor and project management skills are critical.
• Ability to manage multiple competing priorities and adapt to changes.
• Strong communication, interpersonal, and problem solving skills.
• Must be comfortable working in a fast-paced environment.
• Global studies (multiple countries and sites) experience required.
• Previous experience in the pediatric trials and rare disease is an asset.
• Able to work in a team and within a multi-disciplinary environment.
• Strong working knowledge of GCP/ICH and other applicable regulations/guidelines, required
• Proactive approach
• Languages: Strong written and verbal English required.
• Travel Requirements: Domestic or internation travel may be required. The position is remote based, though travel will be necessary prerequisite in order to support the program.

All your information will be kept confidential according to EEO guidelines.