Associate Director, Clinical Data Manager Job at iconplc

Associate Director / Director, Clinical Quality Assurance

Location

United States , Cambridge

Salary:

185000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

University degree in a scientific discipline/life sciences OR equivalent experience in biotech/pharmaceutical industry
Experience in a clinical stage biotech company preferred
10+ years of relevant experience in clinical/GCP quality
Outstanding expertise in GCP R3 and solid understanding of PV regulations
Demonstrated ability to successfully partner cross-functionally
Excellent interpersonal effectiveness, including exceptional communication skills
Advanced computer skills, including experience working in Veeva
Consistent excellent judgement and pragmatic, risk-based decision making skills
Direct experience supporting FDA and other global healthy authority (e.g., EMA, MHRA) inspections and related inspection preparation activities

Job Responsibility

Lead development and execution of enterprise-wide GCP inspection readiness strategies and plans
Conduct inspection risk assessments and coordinate mock inspections, readiness reviews, and remediation activities
Support health authority inspections, including document review, response coordination, and follow-up remediation activities
Serve as the Clinical QA Lead for assigned studies and programs
Provide quality review of protocols, informed consent forms, investigator brochures, CSRs, and regulatory submission documents
Develop and execute program/study-level risk-based audit plan, including investigator site, vendor and internal process audits
Provide quality oversight of CRO and key service providers through qualification, ongoing monitoring, and issue escalation
Provide QA oversight of TMF quality and completeness in collaboration with study teams and TMF group
Support TMF migration activities, as required
Lead quality investigations, root cause analysis, and CAPA development

Fulltime

Associate Director / Director, Data Management

Reporting to the Senior Director, Clinical Data Management, the Associate Direct...

Location

United States , Cambridge

Salary:

185000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

BS or MS degree in a scientific or health-related field
10+ years of experience in clinical data management within pharmaceutical/biotech and/or CRO environments
Demonstrated sponsor-side ownership of Phase I, II and III studies, from start-up through closure for multiple clinical studies
Strong hands-on experience with EDC systems (e.g., Medidata RAVE, Veeva EDC, Oracle Inform)
Deep knowledge of CDASH/CDISC, GCP/ICH, and FDA regulatory expectations
Proven experience overseeing CROs and external data vendors
Experience developing reports using J-Review and/or other CDM reporting tools
Prior IND, as well as NDA/BLA (filing/submission) experience, is highly desirable
Must be self-motivating, with strong analytical, organizational, and communication skills, with the ability to manage complexity across multiple studies
Demonstrated ability to navigate evolving priorities and drive timelines forward with focus and composure in a fast-moving organization

Job Responsibility

Lead sponsor side clinical data management activities across multiple concurrent studies within a defined therapeutic area
Own data management execution from study start-up through database lock and archival for concurrent studies, including late stage and registrational trials
Ensure data quality, integrity, and traceability to support interim analyses, CSRs, DSURs, IB updates, and program specific regulatory interactions
Proactively identify data risks, trends, and operational dependencies
Serve as the primary data management contact for CROs and third-party data vendors
Oversee outsourced CDM activities to ensure timely, high-quality deliverables aligned with sponsor’ expectations
Monitor CRO and vendor performance, escalating risks and proposing mitigation strategies
Contribute expert input to the development and evolution of data management standards, processes, tools/systems and vendor operating models
Provide hands-on leadership for CRF design and cross functional review, Edit check specifications and user acceptance testing, Data Management Plans and CRF Completion Guidelines, External data transfer specifications
Apply CDASH/CDISC expertise and partner with Statistical Programming to support SDTM readiness, validation outputs, Reviewer’s Guides, and define.xml

Fulltime

Associate Director, Clinical Quality Assurance

We are seeking a dynamic and results-driven Associate Director of Clinical Quali...

Location

United States

Salary:

170000.00 - 190000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant biological sciences or equivalent is required, advanced degree a plus
8-10 years professional experience in Quality Assurance within the biopharma industry, including increasing responsibilities in the Clinical QA function
Minimum of 6 years of direct audit experience in GCP
In-depth working knowledge of GCP regulations and guidelines, including FDA, EMA, and ICH requirements
Extensive experience using electronic QMS to monitor, report, and track quality tasks and key quality performance indicators
Strong communication (oral and written), effective interpersonal skills with the ability to listen and drive change
Excellent problem-solving and critical thinking abilities
Flexible and creative to meet the needs and challenges of a growing, dynamic company
Focus on fostering a culture of collaboration and teamwork
Ability to manage multiple projects with aggressive timelines and changing priorities

Job Responsibility

Assist CQA Leadership with development and execution of CQA audit plans supporting Apogee clinical study programs
Perform or provide oversight of assigned GCP audits e.g. clinical investigator sites, clinical vendor qualifications, trial master files, internal processes and clinical study documents with minimal supervision
Act as CQA lead representative at clinical study team meetings and other study related meetings
Partner with clinical functions to provide quality guidance as required to drive the implementation of fit for purpose procedures that support clinical data and documentation generated activities are executed in compliance with GCP
Facilitate and/or review the investigation of reported quality events to evaluate the appropriateness of CAPAs proposed to mitigate risk of issue re-occurrence
Contribute to the development and maintenance of clinical QA procedures and other governance standards as assigned
Assist in the periodic reporting of key quality metrics to leadership to assist in driving improvements in GCP compliance across the organization
Assist in the development and/or delivery of GCP training topics and quality standards as directed
Assist QA Leadership in fostering a culture of quality and continuous improvement within the organization, emphasizing the importance of compliance, data integrity, and patient safety in support of corporate goals
Collaborate with clinical functions to support inspection readiness activities

What we offer

A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

Clinical Scientist Associate Director – Late Development, Oncology

Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part...

Location

Portugal , Lisbon

Salary:

79656.90 - 107771.10 EUR / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 3 years of life sciences/healthcare experience
Master's degree and 5 years of life sciences/healthcare experience
Bachelor's degree and 7 years of life sciences/healthcare experience

Job Responsibility

Support set up and execution of late phase clinical trials with a focus on data quality
Assist in authoring clinical protocols, Investigators Brochures and other regulatory documents ensuring consistency and clarity
Provide input into and implementation of data management plan, CRF design, and data review oversight
Support review, analysis, and presentation preparation of clinical trial data for internal decision making, external interactions, and regulatory submission
Assists the management of collaborators, consultants, and/or Clinical Research Organizations in completion of key projects
Anticipate and actively manage problems across a broad spectrum of cross-functional teams
Work cross-functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents
Support appropriate training, recruitment, and development requirements for matrix team resources

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
Discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible

Fulltime

Clinical Scientist Associate Director

In this role, the Clinical Scientist Associate Director supports the design, exe...

Location

Spain

Salary:

90787.65 - 122830.35 EUR / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 3 years of life sciences/healthcare experience
Master’s degree and 5 years of life sciences/healthcare experience
Bachelor’s degree and 7 years of life sciences/healthcare experience

Job Responsibility

Support the design, start-up, and execution of global clinical trials, ensuring adherence to protocol, regulatory requirements, and data integrity standards
Contribute to development of clinical protocols, statistical analysis plans, investigator brochures, and regulatory documents, with focus on study endpoints, key efficacy outcomes, and safety assessments
Collaborate with cross-functional teams to support endpoint strategy, event adjudication processes, and safety monitoring
Participate in development and oversight of endpoint adjudication charters, safety monitoring plans, and Data Monitoring Committee (DMC) interactions
Provide clinical input into data management plans, CRF design, and clinical data review, with focus on key study endpoints, efficacy and safety outcomes, and/or imaging or biomarker endpoints, as applicable
Conduct ongoing clinical data review and signal detection, supporting identification and resolution of safety and data quality issues across global trial sites
Support preparation and interpretation of interim analyses, database lock activities, and top-line data readouts
Assist Development Lead and Clinical Scientist Director with medical monitoring activities and oversight of CROs, vendors, and adjudication committees
Collaborate with clinical operations, biostatistics, safety, regulatory, and medical affairs teams to ensure successful delivery of clinical studies across relevant indications and endpoint strategies
Contribute to clinical study reports, regulatory submissions, scientific publications, and presentations for internal and external stakeholders

Fulltime

Associate Director, Regional Clinical Operations

Associate Director, Regional Clinical Operations. ICON plc is a world-leading he...

Location

United States , Atlanta; Houston; Tampa; Dallas

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Minimum Bachelor’s degree with 5-7 years of experience in Clinical Trial Operations in pharmaceutical / biotechnology industry or Clinical Research Organization, or equivalent, including at least 3 years in a role of primary responsibility for clinical trial execution and management
Thorough understanding and experience in global clinical trials in a diverse range of patient populations with preferred experience in both oncology and hematology
Direct management experience and supervisory responsibility
Demonstrated leadership and management skills
Goal oriented, self-starter with proven ability to work independently
Good knowledge and experience working with external specialist vendors
Excellent interpersonal, organizational, problem-solving, and written/verbal communication skills, confidence, and ability to work effectively with a wide variety of medical, research and administrative personnel
Able to proactively identify issues and provide potential solutions for resolution
Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines and to established quality standards
Proficient in Outlook/Word/Excel/PowerPoint

Job Responsibility

Accountable for oversight of all assigned studies within the country in accordance with the overall development plan and clinical operations plan and under the direction of the global team (Global Clinical Trial Manager), including adherence to quality, timelines and budget
Accountable for planning and executing assigned country study goals and commitments, and as needed, leading, organizing, and participating in regional and/or local meetings and training sessions to implement country-level recruitment plans
Develops, builds and maintains optimal relationships with key institutions within the country (i.e. Site Alliance Sites), working closely with the Medical Science Liaisons, Global Site Management and Central Services, and other departments as indicated according to the Site Engagement Strategy
Drive the identification and inclusion of sites that have access to and can enroll patients who are from groups that have been historically underrepresented in clinical trials (per FDA Guidance for Industry for Improving Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials)
Oversees regional study feasibility, site monitoring performance, quality metrics and all relevant activities for assigned studies
Drives evidence-based site recommendations and selection
Provides support and training for sites to support diverse recruitment and retention, review, assist and optimize site-level diversity plans as needed, check and challenge progress and coordinate and align central efforts across sponsor and CROs
Align local and central initiatives and advise and guide on effective community engagement activities
Conduct co-monitoring and site identification visits, as needed
Collaborates cross-functionally to build and maintain strong relationships and interaction at the country local level (i.e. Medical Science Liaisons, Medical Monitors, Clinical Scientists, etc.) that directly contribute to key study activities and milestones

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Associate Director Regional Clinical Operations

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

United States , Boston, Philadelphia, PA

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Minimum Bachelor’s degree
5-7 years of experience in Clinical Trial Operations in pharmaceutical / biotechnology industry or Clinical Research Organization, or equivalent
At least 3 years in a role of primary responsibility for clinical trial execution and management
Thorough understanding and experience in global clinical trials in a diverse range of patient populations
Preferred experience in both oncology and hematology
Direct management experience and supervisory responsibility
Demonstrated leadership and management skills
Goal oriented, self-starter with proven ability to work independently
Good knowledge and experience working with external specialist vendors
Excellent interpersonal, organizational, problem-solving, and written/verbal communication skills

Job Responsibility

Accountable for oversight of all assigned studies within the country
Accountable for planning and executing assigned country study goals and commitments
Develops, builds and maintains optimal relationships with key institutions within the country
Drive the identification and inclusion of sites that have access to and can enroll patients from underrepresented groups
Oversees regional study feasibility, site monitoring performance, quality metrics
Provides support and training for sites to support diverse recruitment and retention
Conduct co-monitoring and site identification visits
Collaborates cross-functionally to build and maintain strong relationships
Communicates regularly on country study status and escalates unresolved issues
Collaborates with the Global Study Team to develop and execute risk management plans

What we offer

Competitive salary
Various annual leave entitlements
Range of health insurance offerings
Competitive retirement planning offerings
Global Employee Assistance Programme, LifeWorks
Life assurance
Flexible country-specific optional benefits

Fulltime

Clinical Scientist Associate Director - Late Development, Oncology

In this role, the Clinical Scientist Associate Director supports late-phase clin...

Location

Portugal , Lisbon

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 3 years of life sciences/healthcare experience
Master’s degree and 5 years of life sciences/healthcare experience
Bachelor’s degree and 7 years of life sciences/healthcare experience
3 years of pharmaceutical clinical drug development experience
Demonstrated experience contributing to clinical trial process improvements within a therapeutic area or study team environment
Industry or academic experience supporting early or late-phase drug development within a relevant therapeutic area or disease indication
Strong communication and presentation skills in English
Experience supporting the design, monitoring, and implementation of clinical trials in compliance with Good Clinical Practice standards and applicable regulatory requirements
Working knowledge of study data readout activities, including data cleaning, database lock, data extraction, and generation of clinical data outputs
Experience contributing to regulatory submission documents and supporting clinical regulatory responses for health authority interactions under guidance

Job Responsibility

Support set up and execution of late phase clinical trials with a focus on data quality
Assist in authoring clinical protocols, Investigators Brochures and other regulatory documents ensuring consistency and clarity
Provide input into & implementation of data management plan, CRF design, and data review oversight
Support review, analysis, and presentation preparation of clinical trial data for internal decision making, external interactions, and regulatory submission
Assists Development Lead and Medical Sciences Director in medical monitoring and management of collaborators, consultants, and/or Clinical Research Organizations in completion of key projects
Anticipate and actively manage problems across a broad spectrum of cross-functional teams
Work cross functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents
Support appropriate training, recruitment, and development requirements for matrix team resources

What we offer

Vast opportunities to learn, develop, and move up and across our global organization
Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act
Generous AMGEN Total Rewards Plan comprising healthcare, finance, wealth, and career benefits
Flexible work arrangements

Fulltime

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Associate Director, Clinical Data Manager

Job Description

Job Responsibility

Requirements

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