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Clinical Pharmacology Study Manager

Date: Mar 21, 2019

Location: Deerfield, Illinois, US

Company: Lundbeck

At Lundbeck, we believe life is too precious to be interrupted by brain disorders. Lundbeck is uncompromisingly committed to the research, development and delivery of targeted therapies for people living with significant psychiatric and neurological disorders. We pursue imaginative solutions, driven by passionate people committed to do the right thing for our patients, our company and our communities. Lundbeck strives to be a leader in depression, schizophrenia, Alzheimer's disease and Parkinson's disease. 

 

For Lundbeck, making a meaningful difference for patients is more than an aspiration; it is a commitment that shapes everything we do. Patient advocacy is at the core of who we are and motivates every individual at Lundbeck. Our engagement with the communities we serve grants us better understanding of the needs of patients and their families; and that drives us to develop innovative therapies and impactful programs for patients and caregivers.

 

SUMMARY:

The Clinical Pharmacology Study Manager (CPSM) is responsible for the management of Clinical Pharmacology studies in accordance with standard operating procedures (SOPs) and ICH Good Clinical Practices (GCP) so that recruitment targets are met and quality data is produced within the required timelines. The CPSM reports to the Chief Specialist, US Clinical Pharmacology and works closely with the Head of Clinical Pharmacology Operations.

 

ESSENTIAL FUNCTIONS:

  • Performs day-to-day operational management of study site in collaboration with Clinical Pharmacology Scientist. Assesses site facilities, equipment and procedures and establishes study timelines. Manages all trial supplies. Develops effective working relationships with site staff, and proactively resolves study issues in collaboration with site staff.
  • Leads the Study Management Team. Organizes multiple (3-4) clinical pharmacology studies according to ICH-GCP, local regulations, and SOPs. Writes the protocol based on input from Study Design Group. Coordinates Study Management Team (SMT) members’ comments and collates and finalizes comments into final protocol. Coordinates applicable RA and EC approvals. Initiates and finalizes all work orders. Reviews Case Report Forms (CRFs). Performs ICF GCP and operational review. Performs operational management of all Contract Research Organizations (CROs) and vendors supporting the study. Writes Study Operations Manual, and reviews data management plan and Clinical Study Report (CSR). Reports in a timely manner all site interactions.
  • Performs pre-trial visits, site initiation visits, and CRO Stand Operation Procedure (SOP) reviews as required. Provides on-going training to site staff.
  • Participates and assists as necessary in audits and inspections and follows up on any findings.
  • Performs timely collection, Quality Control (QC), and submission of essential documents required before initiation of an investigative site. Performs ongoing QC of study documentation, including uploading of documents into the electronic trial master file (eTMF).
  • Manages site specific RA and EC issues. Assists in review of documents required for RA and EC submissions performed by the CRO or the Lundbeck Regulatory Department.
  • Actively participates in Clinical Pharmacology and UK department meetings.
  • Undertakes other projects as and when required at the request of the Head of Clinical Pharmacology/Head of Clinical Pharmacology Operations CQP/UK.
  • Maintains highest standards for regulatory compliance at all times.

 

REQUIRED EDUCATION, EXPERIENCE and SKILLS:

  • Accredited Bachelor’s Degree with:
    • 3+ years experience in pharmaceutical, biotech, or CRO industry.
    • 2+ years of clinical study site monitoring experience or in-house study management experience.
    • 1+ year of clinical study coordination or management for drug development.
    • History of managing sites in Pharma-sponsored clinical pharmacology studies intended for use in NDA applications to FDA including monitoring visit scheduling, clincial site management, site training, site communication, query resolution, and generation of trip reports.
    • Experience in effectively training site personnel in clinical pharmacology studies 
  • OR Accredited PharmD or PhD in a pharmaceutical or healthcare related field
  • Knowledge of appropriate GCP, ICH and CFR regulations.
  • Proficiency in using Microsoft Word, Excel, and Powerpoint.
  • Effective scientific writing skills.
  • Ability to function in an independent manner.

 

PREFERRED EDUCATION, EXPERIENCE AND SKILLS:

  • Accredited PharmD or PhD in a pharmaceutical or healthcare related field
  • Experience in performing in-house support on clinical pharmacology studies (e.g., essential document review, liaison with CRO).
  • Experience in a variety of therapeutic areas.
  • Experience in monitoring and assisting with the management of clinical pharmacology studies.

 

TRAVEL

  • Willingness/Ability to travel up to 30% domestically. International travel is required.

 

Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employement opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.