Associate Director/Principal Clinical Data Manager

Clinical Science · Homebased, Greater London
Department Clinical Science
Employment Type Full-Time

The Associate Director/Principal Clinical Data Manager will be responsible for heading the Data Management function at COMPASS and will oversee data management activities in all COMPASS Pathways sponsored studies.


COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support.


COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). We have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. This was the largest randomised, controlled, double-blind psilocybin therapy clinical trial ever conducted, and our topline data showed a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also running phase II clinical trials of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD) and anorexia nervosa. COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing. www.compasspathways.com


Location: Home based in the United Kingdom (or office based in our London office). 


Reports to: The Associate Director/Principal Clinical Data Manager will report to the Senior Director, Biostatistics. 

 

Roles and responsibilities

Responsibilities include (but are not limited to):


  • Head up the Data Management function and build it up as the company grows
  • Provide data management subject matter expertise within COMPASS
  • Serve as primary liaison to CRO and Vendor data management personnel on assigned COMPASS studies
  • Responsible for selection and oversight of CRO DM vendors to ensure adherence to scope of work and service agreement, and to ensure deliverables are met in accordance with quality, timelines, and budget
  • Assess study data risk management, provide insight on process improvement and solutions, and write and review SOPs when necessary
  • Responsible for Case Report Form (CRF) completion guideline and Data Management Plan(s) development and approval. 
  • Prepare or oversee development of Data Transfer Agreements (DTA’s) between the data management CRO and external data vendors. 
  • Support submissions, audits, and inspections as required
  • May include line management of DM reports

 

Profile:


  • Bachelor’s degree in STEM field and minimum of at least 7 years’ experience specifically in pharmaceutical data management function within Sponsor and/or CRO
  • Demonstrated record of increasing responsibility over time, with evidence of management or supervisory experience and direct or indirect leadership experience
  • Data management experience across all aspects of the clinical study cycle including protocol review, study startup, study conduct, database lock, and study reporting
  • Late-stage development (Phase III) and NDA experience are highly preferred
  • Expert knowledge of data management database systems, eg Medidata RAVE
  • Expert knowledge of 21 CFR Part 11 regulations and regulatory submission requirements
  • Expert knowledge of industry standards, ICH guidelines, Good Clinical Practice guidelines, and current clinical data management best practices
  • Strong project management skills
  • Strong working knowledge of CDISC standards (CDASH and SDTM) and familiar with medical coding dictionaries MedDRA and WHODrug
  • Strong technical skills, including working knowledge of SDTM
  • SAS programming experience highly preferred
  • Highly developed analytical and communication skills
  • Ability and desire to work with substantial autonomy and as a cross-functional team member
  • Ability and desire to found the data management function within COMPASS


Equal opportunities: 


UK applicants

We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability.

Thank You

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  • Location
    Homebased, Greater London
  • Department
    Clinical Science
  • Employment Type
    Full-Time