Website Sparrow Pharmaceuticals
Sparing patients the ravages of steroids
Sparrow Pharmaceuticals is a biopharmaceutical company determined to discover, develop, and deliver innovative therapies that target toxic cortisol levels and unlock the potential of corticosteroid medicines such as prednisone. Sparrow is led by an experienced team of scientific thinkers, disruptors and entrepreneurs. We are developing novel therapies to address the key limitations of treatments for endogenous Cushing’s syndrome (Cushing’s), autonomous cortisol secretion (ACS), and polymyalgia rheumatica (PMR). Backed by world-class investors, we are prepared to take our medical products through the entire development continuum – from clinical trials through regulatory approval to commercialization.
The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more therapeutic areas, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.
The Clinical Project Manager (CPM) will have demonstrated ability to oversee all operational aspects of Phase I-III clinical trials with minimal oversight to achieve a high-quality study data for the regulatory submission, commercialization and business success for Sparrow.
Essential Job Functions:
Study Management & Leadership
Ability to oversee multiple clinical studies and CRO vendors
Reports on key study performance information and cycle time metrics pertaining to time, cost and quality deliverables, e.g., study start-up metrics, enrollment, data collection timeliness, etc.
Leads the development of the clinical study plan including critical path activities and interdependencies for assigned clinical study
Provides operational input into study protocols, informed consent and amendments
Assists in the review and or development of the core study documents, plans and processes.
Proactively assesses potential risks to the study and proposes risk mitigation plans.
Provides study specific oversight of site feasibility, enrollment projections and site identification activities.
Develops and drives study timelines, milestones, site and study level budgets and accountable for providing monthly and yearly financial estimates. Responsible for tracking study budget and payments and forecasting study spend.
Reviews and approves site and vendor invoices, including investigator grants and pass-through costs.
Ensures oversight of TMF with periodic audits
Verifies that all relevant IT-systems are updated with current and accurate information (e.g., CTMS, eTMF).
Ensures compliance to regulatory and GCP, and internal processes
Plans and coordinates IMP and non-IMP supplies
Contributes to development of proactive strategies and corrective action plans as needed to address study issues
Identifies, implements, leads and manages a cross-functional Team for the duration of the study, working with management to identify team members and resolve issues and disseminates relevant information to team members in effective and timely manner.
Triages, resolves and/or escalates study issues /risk mitigations to Head of Clinical Operations
Has routine interaction with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries
Responsible for the oversight, performance, and management of CROs and vendors to ensure compliance with quality measures and adherence to scope of work within timelines and budget at a task level. Specifically tracks operational study timelines and monitors operational performance metrics through the life of the study; Identifies issues and proposes solutions.
Responsible for ensuring that vendors provide timely input and generate documents in a timely manner and with quality.
Responsible for overseeing CRO to ensure that essential site documents are collected, and sites are initiated per study plan, enrollment is on target and mitigation plans are in place.
Coordinates, prepares for and executes meetings including but not limited to team meetings, investigator meetings and training.
Helps to ensure team and external partner(s) receive and document study specific training
Other tasks as assigned
Experience / Education
A Bachelor’s degree (life science preferred) or certification in a related allied health profession (i.e., nursing, medical or laboratory technology) from an appropriately accredited institution
7 – 8 years of increasing responsibility in industry clinical operations including at least 3 years clinical operations experience as study or program lead, and direct experience in global (ex-US) multicenter trials.
2 – 3 years of Monitoring experience preferred.
Knowledge / Skills / Abilities:
Knowledge of all phases of drug development: Phase I – IV global clinical trials
Extensive and comprehensive knowledge of Good Clinical Practice (GCP), Federal Regulations and International Regulations (International Harmonization Committee-ICH Regulations).
Demonstrated ability to comprehend complex scientific concepts and data. Proficient in reviewing and assessing clinical data.
Excellent interpersonal and decision-making skills. Demonstrates innovation. Possesses drive, energy, and enthusiasm to deliver the program objectives
Demonstrated project management skills including simultaneous management of multiple projects. Possesses excellent planning, time management & coordination skills.
Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs.
Excellent written and oral communication skills.
Maintains computer literacy in appropriate software
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