Clinical Lead II/III - Bulgaria
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 II/III 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.
As a Clinical Lead here at Premier Research, you’ll have the opportunity to work in diverse therapeutic areas and will be empowered to plan, schedule, manage, and deliver all clinical operations aspects of a study. You will manage all channels of communication and demonstrate enhanced judgement in selecting the proper mode of communication for the situation. This role is adept at managing the proper escalation points based on the circumstances and keeps other departments informed of developments affecting their functions. This is a high touch internal and external customer service role, so you’ll communicate directly with the sponsors, sites and internal project team members.
What you’ll be doing:
- Manage clinical portion of the trial in a patient centric approach and proactively identifying risk, potential patient safety events, and maintain oversight for data integrity.
- Successfully oversee and monitor CRAs in a matrix environment with a focus on quality and timely deliverables; address issues with appropriate team and line manager; direct involvement in selection and activation of investigative sites; ensure 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
- Proactively maintain compliance through identification/mitigation of risk and ensuring adherence to ICH, GCP, SOPs, and the study protocol over the life of the study.
- Drive the successful activation of trial sites according to time, quality/scope and budget parameters
- Plan and drive 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 motivate recruitment in order to meet milestones
- Collaborate 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 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
- 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
- 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; 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; apply a risk-based quality management mindset in order to proactively mitigate issues and also provide support for study audits and responses
- Work with Project Management and Financial Analyst to accurately forecast clinical tasks including monitoring visits
- Actively participate in Bid Defense activities
You’ll need this to be considered:
- Bachelor’s degree in life science
- 7 years of clinical research experience as a CRA
- Min. 2 years of experience as Clinical Lead
- At least 2 years previous clinical oversight experience or equivalent (PM-CL)
- Working knowledge of clinical financials including understanding of budgets, pass- through and resource management
- Strong knowledge of ICH / GCP regulations; advanced knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures
- Strong knowledge of web based communication tools, and MS Office computer skills
- Fluent verbal and written English as well as the local language(s) required
- Known for being customer-focused in approach to work and communications with the ability to professionally interact with sites, clients, vendors and other functional areas; strong verbal and written communication and negotiation skills
- Maintains a positive, results orientated work environment; excellent team player, collaborative and able to build an effective team; Strong people management skills to motivate, enthuse, and lead
- Excellent organizational and time-management skills, able prioritize work to meet deadlines; ability to multitask and work effectively in a fast-paced environment with changing priorities; accountable, dependable and strong commitment.