Clinical Lead I (Late Phase) - Remote
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.
We’re looking for an exceptional Clinical Lead I to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.
At Premier Research, we are science-minded and heart-centered. Join us.
The Clinical Lead I (CL I) is ultimately responsible for planning, scheduling, managing, and delivering all clinical operations aspects of a study.
The CL I optimally uses all channels of communication and demonstrates good judgement in selecting the proper mode of communication for the situation. This role understands the proper escalation points based on the circumstances and keeps other departments informed of developments affecting their functions.
The CL I is typically assigned to studies that are low to moderate in complexity. The CL I may be assigned onto a global study but generally will manage the region where the CL I is located.
Expected activities include the successful selection, activation, and management of CRAS and investigative sites in a matrix environment. The CL I is also responsible for maintaining compliance through ensuring adherence to ICH, GCP, SOPs, and the study protocol over the life of the study.
This role provides high touch internal and external customer service by establishing, maintaining, and enhancing relationships with sponsors, internal teams, and investigative sites. The CL I takes a patient centric approach to the clinical management portion of the trial.
- Drives the successful selection/activation of trial sites according to time, quality/scope and budget parameters
- Plans and drives both patient recruitment and retention together with the project manager (PM), inclusive of preparing and executing a site and patient recruitment and retention plan/strategy to drive recruitment in order to meet milestones
- Works cross functionally with PM, Data Managers (DM), Clinical Monitoring Services team (CMS)… to deliver project deliverables
- Moves the project/program forward and leads in-country projects where applicable
- Create and maintain in a timely fashion a study specific clinical monitoring plan (CMP) utilizing approved templates; ensure effective communication and escalation instructions are incorporated in the CMP and actioned appropriately
- Leads, manages and actively monitors/oversee the clinical monitoring team with a focus on quality and timely deliverables; addressing any issues with the appropriate team member and their line manager
- Ensures the timely completion of all visit reports, reviews them for appropriate content to ensure quality, GCP compliance, finalization within contractual timeline and effective follow up and resolution of site issues
- May co-monitor or audit CRAs according to project and business needs
- Monitors clinical operations metrics, activities and timelines on a regular basis; Tracking and analysis of open actions, protocol deviations, queries aging reports, and assesses the financial health of the clinical aspect of the study
- Ensures timely data verification through review of data management reports and use of monitoring resources to optimize monitoring of clinical data (i.e. pending SDV, missing pages, and aging queries)
- Collaborates with Project Manager to establish clinical project timelines and accomplish all milestones throughout the study
- Understand and adhere to the contractual and budgetary obligations of the study
- Drive the clinical team forward to meet contractual milestones such as first site activated, first patient in, last patient in, and database lock
- Deliver and/or coordinate appropriate and timely training to the Premier clinical team and enlist therapeutic assistance where applicable to ensure the validity, correctness, and completeness of the clinical data and conduct of the study as dictated by applicable global regulations, Premier SOPs, ICH-GCP, protocol and client requirements
- Complete/contribute to the review of the protocol/study design, informed consent forms and be a reference point for CRAs and investigative sites
- Apply clinical and monitoring expertise in the design of case report forms · Serve as initial point of contact for all clinical management and monitoring concerns, escalating as required
- Work with the Project Manager to ensure transparent and proactive sponsor and internal communication regarding study progress and trial issues
- Assist the project team in the creation and maintenance of the Trial
- Master File according to Premier Research and/or client SOPs and ensure all visit report packages are filed according to SOPs ·
- Contribute to the risk management plan and contribute to set up of adaptive risk monitoring system with the PM on an ongoing basis in order to mitigate unexpected clinical events in the conduct of the trial
- Work with the Data Management team to identify data related issues and risks to clinical activities; assist in the development of mitigation plans to minimize risk
- Apply a risk-based quality management mindset in order to proactively mitigate issues and also provide support for study audits and responses · Work with the PM and appropriate line managers to ensure team members are adequately resourced to the project for the entire duration of the study
- Assist the PM to ensure appropriate transition planning and stakeholder communication for any change in clinical staff ·
- Provide detailed Time Entry Guidelines to the Premier clinical staff as determined from the study algorithm for each clinical task, and provide applicable training on the guidelines ·
- Identify out-of-scope tasks from the Premier clinical team and ensure pre-approval of these tasks by the PM and Sponsor, as required
- Provide performance feedback on project team members for annual appraisals
- Work with Project Management and Financial Analyst to accurately forecast clinical tasks including monitoring visits
- Contribute to the creation, review and finalization of Root Cause Analysis and CAPA
- May participate in Bid Defense activities
- Other activities as designated
- Bachelor’s degree, or its international equivalent from an accredited institution, in a clinical, biological, scientific, or health-related field; or equivalent work experience
- 5 years of clinical research experience as a CRA, CL or PM at least 2 years onsite monitoring or 3 years remote monitoring experience is required, or 8 years of clinical research experience as a CRA, CL or PM of which at least 4 years of clinical monitoring experience is required
- Presenting information to various levels of stakeholders
- Providing performance feedback on CRAs for annual appraisals
- Effectively communicating expectations using proper oral and written language
- Influencing without authority
- Minimal experience in CL activities (trip report review…)
- Good knowledge of ICH / GCP regulations
- Working knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures
- Sound knowledge of web based communication tools
- Strong MS Office computer skills
- Fluent verbal and written English as well as the local language(s) required
- People management skills to motivate, enthuse, and lead
- Collaborative team player with demonstrated ability to drive consensus
- Ability to multitask and work effectively in a fast-paced environment with changing priorities
- Negotiation skills
- Effective presentation skills
- Strong organizational and time-management skills, able to prioritize work to meet deadlines
- Accountable, dependable and demonstrated commitment
- Self-starter with ability to act on own initiative
- Is customer service focused in approach to work, both internally and externally
- Maintains a positive, results oriented work environment