Clinical Project Manager II, Real World 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 Project Manager II 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 RWLP Clinical Project Manager II is ultimately responsible for project and clinical delivery related to the execution of Ph IV clinical trials that are moderate to high in size and complexity with regards to agreed time, scope, cost and quality, acting as main client contact.
4 years’ experience within pharmaceutical/biotech/medical device/CRO with related project management or clinical management experience
Specific international Ph IV interventional and non-interventional & Real-World Evidence studies (PASS, observational, natural history, registries, ...) hands-on expertise, experience in De-Centralized Trials/ Hybrid design and /or Low Interventional strategy, is required.
- The RWLP Clinical Project Manager is ultimately responsible for project and clinical delivery with regards to agreed time, scope, cost and quality, acting as main client contact.
- Facilitating cross-functional teamwork within the project team (especially CRAs, Start-up and Regulatory, Feasibilities, PV, DM, SAS Programming) and with KOL and sponsor representatives, to ensure the successful completion of your protocols.
- Design, tracking and revision of project plans, work allocation and KPIs for specified metrics.
- Meet financial performance targets such as accurate forecasting, revenue recognition, profit margin maintenance and out of scope responsibilities.
- Drives the successful selection/activation of trial sites according to time, quality/scope and budget parameters
- Plans and drives both patient recruitment and retention, inclusive of preparing and executing a site and patient recruitment and retention plan/strategy to drive recruitment in order to meet milestones
- Leads, manages and actively monitors/remote monitors/oversee the clinical monitoring team
- Ensures the timely completion of all visit reports, timely data verification through review of data management reports and use of monitoring resources to optimize monitoring of clinical data
- Complete/contribute to the review of the protocol/study design, informed consent forms and be a reference point for CRAs and investigative sites
- 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
- Participate in proposal development and sales/bid defense presentations
- Training & mentoring in multiple areas of expertise .
- Contributing to performance feedback
- Advance degree, PhD and/or MBA re equilvalent experience preferred
- 4 years’ experience within pharmaceutical/Biotech/medical device/CRO with project management or clinical management experience
- Specific international Ph IV interventional and non-interventional & Real-World Evidence studies (PASS, observational, natural history, registries) hands-on expertise, experience in De-Centralized Trials/ Hybrid design and /or Low Interventional strategy, is required
- Ability to multitask, meet deadlines, and work effectively in a fast-paced environment with competing priorities
- Excellent organizational and time-management skills
- Effective teamwork in matrix structure ,
- Problem solving
- 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
- Fluent verbal and written English
- Strong verbal and written communication skills
- People management skills to motivate, enthuse and lead the team
- Willingness to travel
- Maintains a positive, results orientated work environment