Senior Clinical Pharmacology Study Manager
707 - Clinical Research
Senior Clinical Pharmacology Study Manager
No company knows the brain better. Lundbeck is uncompromisingly committed to the research, development and delivery of targeted therapies for people living with significant psychiatric and neurological disorders. At Lundbeck, we believe life is too beautiful to be interrupted by brain disorders. So, 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. Our advocacy for patients isn’t an invented “company value” – it is at the core of who we are and motivates every individual at Lundbeck. Our ongoing engagement with patient communities is not what you might expect from a pharmaceutical company – we create our own programs to help patients and caregivers not simply manage their conditions but thrive in spite of them.
The Clinical Pharmacology Study manager (CPSM) manages multiple global clinical pharmacology studies of varying complexity in several different compounds/disease indications in both healthy volunteers and patients with minimum support and must demonstrate an understanding of the different country specific regulations and guidelines. Actively participates in Clinical Pharmacology and Affiliate meetings and works with cross-functional teams to ensure timely execution and completion of Clinical Pharmacology trials while ensuring compliance with applicable regional and/or global regulations.
- Participate in department cross-functional teams at the program level.
- Manage multiple global clinical pharmacology studies of varying complexity in several different compounds/disease indications in both healthy volunteers and patients with minimum support. This includes complex pharmacodynamics (PD) using multiple vendors and non-PD studies. Studies include multiple site studies and those using academic centers.
- Manage studies in Europe, US and Asia-Pacific and demonstrate an understanding of the different country specific regulations and guidelines.
- Manage the Study Management Team (SMT), including planning and leading the SMT meetings, during the entire study life cycle from protocol design to final Clinical Study Report (CSR).
- Ensure the protocol is written based on the study design created by the Study Design Group, providing advice on operational tasks so that they are feasible. Ensure input is given to the protocol from SMT members and co-ordinate the reviews between the Lundbeck SMT and external parties. Arrange Protocol scientific and technical quality control (QC).
- Ensure personnel responsible for Competent Authority (CA) and Ethics Committee (EC)/Institutional Review Board (IRB) approvals have all necessary documentation and defined timelines to submit. Provide input and co-ordinate responses to CA and EC/IRB as required.
- Drive review and completion of Work Orders with input from SMT members and relevant external providersReview electronic case report form(eCRF) design to ensure eCRF is consistent with Lundbeck’s study protocol and co-ordinate the site’s and CRA’s review of draft eCRF via attendance at the Screens Review Meeting.
- Review the Informed Consent Form according to Good Clinical Practices(GCP), protocol and Lundbeck standards.
- Write the Study Operations Manual (SOM) to cover the operational tasks on the study and ensure that it is final prior to study start (FSFV). Agree and arrange sample shipment dates between parties and ensure rater training is performed as applicable to the study.
- Ensure good working relationship is built with all external providers of services and ensure that they are aware of each study’s requirements and timelines.
- Review the Clinical Study Report to ensure all operational details from the study are correctly represented.
- Assess site facilities, staff, equipment and review standard operating procedures (SOPs) to ensure clinical sites can appropriately and adequately perform studies according to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) GCP.
- Provide ongoing study -specific training and support to clinical site staff and outsourced clinical research associates (CRAs).
- Manage CRAs, CRA monitoring schedules and review monitoring reports.
- Ensure that recruitment rate and quality at site is maintained and support site in achieving recruitment targets within the required timelines.
- Ensure that sites have sufficient study supplies as required from Lundbeck and that all vendors provide services as required by the work orders. Chair set-up meetings with vendors so responsibilities are clearly defined.
- Be the main Lundbeck contact for sites, enabling day-to-day contact to proactively resolve any issues as they arise in a timely manner, to ensure effective management of the study site in collaboration with SMT.
- Ensure studies are organized, managed, performed and reported according to legislations, study protocol, SOPs, SOM and ICH GCP.
- Prepare, participate and assist as necessary in audits/inspections by ensuring study essential documents are appropriately filed at site and in the Sponsor TMF and respond to audit/inspection reports. Ensure that quality data are produced to meet the agreed timelines of study; and compliance with serious adverse event (SAE) reporting procedures and timeframes is achieved.
- Promote Lundbeck's positive image and see that it is maintained and enhanced, ensuring compliance with Lundbeck’s Code of Conduct.
- Provide support to Head of Clinical Pharmacology for vendor lessons-learned, coordination and governance meetings
- Provide support and back up to less experienced CPSMs as required.
- Mentor and provide training as delegated on study procedures.
- Train and support new clinical sites that have never worked with Lundbeck before.
- Provide input to quality improvements in studies and participate in lessons learned meetings with internal and external parties.
REQUIRED EDUCATION, EXPERIENCE and SKILLS:
- Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university
- 7+ years experience in conduct/management of multiple Clinical Pharmacology /Phase 1 studies
- Ability to function in an independent manner
- Experience in effectively training site personnel and CRAs in clinical studies
- Well versed in GCP/ICH regulations.
- Experience in managing US and global clinical trials
- Strong communication and leadership skills and ability to effectively work on remote cross-functional teams
PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
- Accredited Master’s Degree
- 10+ years’ experience in clinical pharmacology or related area
- Phase 2 experience or patient populations
- Excellent written and oral communication skills
- Large molecule and/or CNS therapeutic experience
- Experience with software platforms (Microsoft, statistical, PK/PD, electronic data capture, etc.)
- Willingness/Ability to travel up to 30% domestically. International travel may be required.