SPRIM PRO is seeking a Clinical Project Manager/Senior Clinical Project Manager in the United States with experience in providing CRO solutions for clinical trials.

SPRIM PRO is a growing global company that provides clinical trial and consumer health solutions for biopharmaceutical and biotechnology, medical device and digital therapeutics, and infant nutrition industries. SPRIM PRO provides complete CRO services (Medical writing, biostatistics, site feasibility, regulatory, clinical monitoring, pharmacovigilance, medical monitoring, data management and logistics). Additionally, SPRIM PRO provides services such as digital patient and site rater training, ePRO/PRO development and validation, human factors usability testing, medical marketing, and patient engagement programs. We navigate innovation safely and effectively. We deliver reliable outcomes.

Clinical Trial Project Manager/Senior Clinical Trial Project Manager

You will work in a dynamic team environment with various members of the SPRIM PRO clinical, strategic, business, marketing and financial teams to complete work efforts and contribute to the ongoing development of the SPRIM PRO Clinical Trial CRO and Outcomes Optimization services. This role offers career growth opportunities and the opportunity to join a growing company with various pathways for career advancement available to employees who demonstrate professional excellence.

Responsibilities:

The clinical project manager is the lead for clinical trials from start up through study closeout. They work cross-functionally, leading teams (study start up, feasibility, data management, medical monitoring, biostatistics, medical writing, as well as managing the logistic with the project assigned) through the technical and operational aspects of the projects -- thus securing the successful completion of clinical trials.

The project manager ensures studies are conducted effectively,by supporting both study and Sponsor team members, aims to meet CTA timelines and goals, maintains oversight of the contracts/budgets and ensures audit-readiness at all times.

This role is a multifaceted position in a fast-paced contract research organization. Your responsibilities will include contributing to multiple, diverse areas of the business including:

· Effective leadership of cross-functional teams

· Knowledge of the interdependencies between departments to ensure timelines are met

· Reviews study finances, timesheets, billing to provide effective oversight of study finances

· Ensures early identification of risks through proactive risk management

· Forms successful relationships with sponsors through clear communication and defined expectations and set and manage client expectations

· Builds and manages teams effectively

· Ensures input from key stakeholders in order to make good business decisions

· Effectively communicates study status, issues, risks to executive leadership

· Works with the medical writer and the study team to write protocols, ICFs, study plans, and other study team documents

· Manage multiple vendors such as local CRO’s, labs, central raters/readers, translation services, etc.

· Overseeing the activities of trial sites to ensure they are in full regulatory compliance

· Manage & coordinate materials received from the clinical trial outcomes optimization team such as ePRO/eDiary instrument development and validation, cognitive debrief, human factors and usability testing and patient, caregiver and site-based training

· Able to delegate, effectively prioritizes own and workload of project team members

· Is organized, proficient at multi-tasking with good attention to detail

· Is proactive with great interpersonal skills, leadership and communication

Requirements:

· Bachelor’s or Masters degree in Science-related field or licensed certified health care training or equivalent combination of education and experience

· At least 3 years (preferably 5 or more) in a Project Management position, PMP certification preferred and demonstration of successfully managing clinical and research projects as well as leading study teams

· At least 2 years of experience as PM of multi-center clinical trials across therapeutic areas

· Experience with delivering trials in various therapeutic areas, CNS experience preferred

· Experience starting trial activities with US sites, site investigators & coordinators and budget negotiation as well as working on global clinical trials

· Previous experience managing complex projects and working with team members across multiple levels of an organization

· Focused attention to detail and complex problem-solving abilities from an operational and technical perspective

· Strong work ethic and time management skills, with the ability to juggle multiple work streams, projects and deadlines

· Deep intellectual curiosity, desire and flexibility to learn new topics and pivot as needed

· Excellent analytical and writing skills

· Advanced communication and collaboration skills

· Previous professional experience within Contract Research Organizations (CROs), Pharma companies, eCOA/ePRO vendors or other research institutions preferred

· Flexibility to work across global time zones, as required

· Experience with Electronic Data Capture (EDC), ePRO, CTMS and digital clinical trial software preferred

· Proven financial acumen

· Has knowledge/understanding of clinical development guidelines, regulations, and directives

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Clinical Project Manager