Associate/Clinical Trial Manager
Reports to: Clinical Operations Manager
Why you’re here
With your in-depth knowledge and experiences with clinical research and associated regulations/guidelines, you will play a critical role in ensuring our clinical research programs are executed with quality and excellence; as primary contact for the clinical delivery of the project you are responsible for, you will lead the clinical team on your project to partner with the project manager/lead, other functions, and investigator sites to ensure the clinical timelines are met. Your work will make a difference to our purpose of improving the lives of patients in need, one trial at a time.
What you’ll deliver
- On-time delivery of clinical deliverables, including quality, timeline, and budget
How we’ll measure it
- Clinical deliverables, including quality, timeline, and budgetary milestones, and parameters as defined in the SOW
- Clinical operations related project-level profitability
- Stakeholder satisfaction through feedback, including both internal and external
- Adherence to GLC goals, metrics, and processes as well as appropriate quality standards such as ICH-GCP guidelines and ISO 14155
What you’re responsible for
- Serving as a clinical operations contact for both the sponsors and GLC project team members, representing clinical delivery with the customer, including but not limited to:
- Primary Sponsor contact for clinical operations aspects
- Investigator and Bid Defense Meetings
- Internal and External study team calls
- Project-specific Audits / Inspections
- Managing the clinical operational aspects of projects to support the right subjects and right data to meet contractual requirements throughout the project life cycle; monitoring the quality of deliverables, proactively identifying, resolving, mitigating, and escalating clinical risks and/or issue; coordinating clinical issue escalation and resolution with the project leader
- Provide ongoing training and support to the clinical team. Conduct team meetings and ensure regular communication within clinical team, as well as a cross-functional team; ensure proper meeting agenda and minutes are in place and filed/archived properly
- Developing and maintaining clinical study documents, templates, plans, manuals, and other trial-specific tools as necessary, including, but are not limited to, the monitoring plan, recruitment plan, clinical operations part of the risk management plan, or other plans assigned by the project manager; provide clinical operational input into protocol, project management plan, quality management plan, and other documents when required
- Managing clinical study set-up, maintenance, and follow-up study activities through ongoing tracking and review of study progress. Working independently and cross-functionally to report progress to appropriate clinical management and project management forums. Accountable for approving final sites lists.
- Overseeing trial participants’ recruitment activities, proactively explore and deploy all outreach or digital offerings in consultation with the project and the customer.
- Ensuring monitoring activities are properly executed according to monitoring plan, and trial progress/status; Reviewing and approving site visit reports; ensuring standards for monitoring and reporting are met, including follow-up and issue resolution.
- Maintaining and reviewing protocol deviation tracking; ensuring standards for reporting are met.
- Overseeing the setup and maintenance of the clinical portion of the trial master file (TMF).
- Managing external vendors efficiently if applicable
- Assessing clinical resourcing needs and liaising with Clinical Operations Manager/s to resolve resourcing and/or performance issues
- Collaborate with other functional groups such as Labs, Data Management, Pharmacovigilance, and Biostatistics, where necessary, to support milestone achievement and to manage study issues and obstacles.
- Ensuring adherence to the clinical operations portion of the project budget; identify and consult on clinical tasks that are out of scope.
- Overseeing the quality and ensuring compliance with project-specific plans for all clinical deliverables, performing co-monitoring visits for trial quality assessment purpose
- Mentor CRAs, advise on critical specific study issues and provide performance feedback to management on clinical team members.
- Acting as Clinical Site Manager in a reduced capacity, as required. Conducting accompanied field assessment visits with CRAs, as appropriate.
- Provide clinical operations input into new business opportunities when required
Qualifications & Working Experience
- Bachelor’s degree in a health care or other scientific discipline with 3-4 years clinical research/monitoring experience; or equivalent combination of education, training, and experience, including 0–1-year experience to successfully perform the key responsibilities of the role as a Lead CRA, or Senior CRA or equivalent
- Experience with global studies preferred
Technical knowledge & skills or other requirements
- Solid knowledge of, and skill in applying applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Broad protocol knowledge: therapeutic knowledge and experiences, ophthalmology and/or oncology preferred
- Strong understanding of the Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates
- Expert monitoring skills to independently conduct all types of site monitoring visits
- Able to exercise judgment within defined procedures and practices and to determine appropriate action independently
- Exceptional attention to detail, good documentation skills
- Evidence of anticipating and resolving problems
- Strong communication and interpersonal skills, fostering active exchange of information and ideas
- Well-developed organizational skills in a complex and fast-paced environment.
- Demonstrated ability to lead, mentor and provide clinical guidance to team members.
- Excellent skills using Microsoft Office Suite: MS PowerPoint, MS Word, MS Excel, and CTMS.
- Availability to travel locally and/or internationally.
- A valid driver’s licence and passport.