Associate Director, Clinical Data Management

Описание вакансии

Company introduction:

Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments.  

We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from 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) due to the pressing unmet need in this area.

We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways.

Job overview:

Joining a small but highly effective Clinical Data Management team to support leading and overseeing all data management activities for clinical studies from study start-up to database lock in compliance with departmental SOPs and regulatory guidelines. The Associate Director, Clinical Data Management will represent Compass Data Management in the USA, providing additional time zone coverage for international trials and acting as the Data Management SME in the US for Compass team members, external vendors and regulatory interactions.

Under the direction of the UK head of Clinical Data Management, the Associate Director, Clinical Data Management is responsible for executing, overseeing, and synchronizing the following activities: leading and coordinating initiatives to evaluate and implement efficiencies, protocol review, CRF design and development, development of database specifications, development of edit check specifications, development of the Data Management Plan, development of CRF Completion Guidelines, User Acceptance Testing (UAT), data review, query generation and resolution, data reconciliation, identification and review of protocol deviations, review of adverse events, and maintenance of study documentation in the electronic Trial Master File (eTMF).

Location: Hybrid in our New York City office or remote in the East Coast.

Reports to:Director, Clinical Data Management.

Roles and responsibilities(Include but are not limited to): 

• Contribute or lead development of process initiatives including, DM SOPs, Work Instructions, best practice standards (including data collection standards and implementation of advanced data review technology (e.g. analytic reviews, implementation of AI)
• Accountable and responsible for ensuring the delivery of high-quality data management deliverables and activities from protocol review through database closure and archiving
• Lead design of high-quality EDC CRFs in consultation with cross functional partners that align to the data collection requirements identified in the study protocol, align with internal standards, and accurately reflect study endpoints
• Lead the development of data set-up integration needs for eCOAs, ePROs, eConsent and other data collection technologies as required by the protocol
• Maintain complete and accurate records of study data, reports, and documentation and files in the eTMF as appropriate to ensure compliance with departmental SOPs and all regulatory guidelines
• Perform, and/or oversee the complete and accurate review and processing of clinical trial data, including identification, resolution, and clarification of any missing, inconsistent, or clinically questionable data by the study team and/or sites
• Identify and implement the most appropriate study data management study status/KPIs; analytic checks, data integrity checks and reports to ensure data integrity across Compass portfolio
• Lead data management function in ongoing study CRO vendor selection, qualification, evaluation and oversight
• Author, review, and/or approve data management study documents (e.g., eCRF specifications, annotated CRFs Edit Check specifications, eCRF completion Guidelines, Data Transfer Plans, etc.) and ensure documents are maintained and ready for regulatory inspection
• Support or lead data management function for submissions, audits and regulatory inspections as required
• Leverage project management skills to support and oversee multiple projects outsourced and work in a cross-functional team environment
• May include line management of data management reports
• Perform other duties and responsibilities as assigned

Candidate Profile:

• Bachelor's degree in life sciences, health sciences, or computer sciences field or equivalent combination of education, training, and industry related experience
• A minimum of seven (7) years of clinical data management experience in the pharmaceutical or Clinical Research Organization setting
• Proven track record of strong project management skills and experience managing data management activities
• Experience in vendor selection, partnering, and management
• Expert understanding of clinical data lifecycle, including database design, data structure, database development and testing, query management, data quality review, and database lock procedures
• Late stage development (Phase III) and NDA experience are preferred
• Advanced working knowledge of data collection standards including CDISC, CDASH and experience with medical coding dictionaries (MedDRA and WHODrug)
• Expert knowledge of 21 CFR Part 11 regulations and regulatory submission requirements
• Expert knowledge of clinical data collection systems including EDC, eCOA and other data collection technologies
• Excellent written and verbal communication skills
• Expert understanding of ICH, GCP, and GDP guidelines including previous experience of supporting audits and regulatory inspections

【For NYC】Compensation Description (annually):

Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.

Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity.

【Base salary per annum】:

$160,000—$200,000 USD

Benefits & Compensation:

For an overview of our benefits package and compensation information, please visit  "Working at Compass".

Equal opportunities:

Reasonable accommodationWe are committed to building a workplace where everyone’s wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. 

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.

US applicants

Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law.

Sponsorship:

Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying.

Data Privacy:

All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.