Clinical Project Manager Remote
Clinical Project Manager Remote
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Salary Not Disclosed
1 Vacancy
Job Description
Role Overview
The Clinical Project Manager is a teamplayer 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 IIII). The Clinical Project Manager is a role in the Clinical Development organization who knows how to work closely with vendors and clinical sites.
As a Clinical Project Manager at Glycomine you will play a pivotal role in driving the success of critical clinical programs. Youll provide support and experience to the program and members of our Clinical Development team to ensure the seamless of clinical trials. In this role youll collaborate across diverse functions support key initiatives and promote timely onbudget trial completion that adheres to the highest quality standards.
You will be a member of a team that is responsible for the planning implementation and management of clinical studies by overseeing daytoday operations and directly managing and working with outside Clinical Research Organizations (CROs) clinical sites and their teams and thirdparty vendors. You will thrive in a fastpaced 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.
Responsibilities
- Prepare or review site feasibility reports and support the study team in site selection.
- Ensure efficient and through study startup 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 startup documents (example ethics documents for submission) site Clinical Trial Agreements and start up activities are performed prior to each site activation.
- Assist the Director of Clinical Operations to review the study timelines and milestones are being met.
- Review site visits per Oversight Plan and conduct study oversights as needed.
- 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 ICHGCP 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).
- Be part of the team that manages clinical trials from startup through closeout 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 healthrelated 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 to ensure study progress timelines data integrity and compliance with health authority requirements.
- Domain expertise in drug development with a preference for experience in earlystage clinical trials.
- Strong vendor and project management skills are critical.
- Ability to manage multiple competing priorities and adapt to changes.
- Global studies (multiple countries and sites) experience required.
- Previous experience in the pediatric trials and rare disease is a plus.
- Strong working knowledge of GCP/ICH and other applicable regulations/guidelines required
- Travel Requirements: Remote role requiring up to 25 travel
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
