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Almac Group · 1 day ago

Principal, eClinical Data Management

Lansdale, PA

Full-time

Hybrid

Senior Level, Lead/Staff

7+ years exp

Almac Group is a leading drug development solutions provider in the pharmaceutical industry. They are seeking a Principal, eClinical Data Management to oversee the development of data management standards in support of clinical trials and ensure compliance with regulatory standards.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

Responsibilities

Create Clinical Data Management (CDM) policies / procedures relating to:

Definitions for data types, including but not limited to source, electronic source, received, created (direct events performed), owned (data directly created and acceptable independent use)

Ownership of each data type (e.g., source, metadata) within the trial under GCP by whom

Incoming data (e.g., information security considerations, data handling, acceptable and unacceptable file types)

Data editing, cleaning and / line of sight related to all data types including commercial implications where applicable

CDM process for clinical data cleaning and quality framework

Source data policy definition against received and generated data

Patient Identifiable Information (PII) and data privacy

Standard collection and mapping data definitions, ensuring alignment with industry (CDISC) standards and Health Authority regulations

Definition and implementation of standards relating to data storage and retrieval of data

Define / implement standard approaches for eClinical systems integrations, data transfers and data outputs (e.g., reports, exports) including:

Integrations / data transfers between eClinical systems (e.g., IRT, eCOA, EDC, CTMS, CDMS) with optimal performance and support

Standard suite of data transfers

Complex Innovative Designs (e.g., Master Protocols, Covariate Adaptive Randomization, Adaptive Designs, Custom Algorithms)

Randomization data (e.g., client / external access during live study (e.g. DMC / drug safety reviews), policies / procedures on delivery / access / transfer (i.e., what, when, how)

Stakeholder specific data where applicable (i.e., medication management related data for Clinical Supplies Manager; Randomization data for Biostatistician)

ECOA data including any requirements / best practices for use of validated instruments used for endpoints

For use by Almac stakeholders for the conduct and support of studies (e.g., for internal health-check reviews)

For use in support of Electronic data regulatory submissions (following CDISC, ADAM, SDTM standards / formatting)

Acts as a lead owner across relevant projects and initiatives

Champion technology improvements / tools related to CDM processes

Provide direct support and guidance to internal stakeholders for CDM policies and procedures across key areas (e.g., support, data services, biostatistics, QA)

Promotes and leads standardization, automation, innovation, implementing policies, clinical data standards and process improvement, and technology enhancement in CDM

Identify / evaluate issues, provide strategy and direction for functional areas, and lead the effort for improvement / optimization of CDM

Identifies opportunities for the business to monitor compliance to established procedures and mitigate risk

Build strong relationships with key cross-functional stakeholders acting as CDM Subject matter expert

Develops implementation and operational processes for system implementation and data governance at the R&D level

Managing relationship with eClinical Vendors

Input into feature or product development that allows for visibility & portability of the eClinical product data set at the investigator level

Ensures the business is in alignment with evolving policy, objectives, industry trends, and regulatory guidance

Interacts with clients to consult, manage issues, prepare for new business and maintain relationships

Support business development efforts with RFP and client presentation planning and execution

Assist with client adoption and migration consulting, recommendations and implementation. Support client assessments with key stakeholders to elicit and review business requirements

Qualification

Clinical Data ManagementEClinical TechnologiesData Privacy RegulationsCDISC StandardsSAS/SQLClinical Trial DesignCustomer Service SkillsCommunication SkillsTeamwork SkillsLeadership ExperienceOrganizational Skills

Required

Bachelor's Degree in scientific or healthcare-related field

7+ years of experience communicating directly with clients

7+ years of clinical data management or a similar role in pharmaceutical or clinical research industry

Experience with various e-clinical technologies/software systems

Related work experience in eClinical, pharmaceutical, biotech, or medical device industry/company

Clinical data management processes and best practices

Broad understanding of overall drug development process, clinical trials through all phases

Understanding of clinical trial design, biostatistical and supply management applications

Understanding of FDA 21 CFR Part 11 as it relates to software solutions

Understanding of data privacy and protection regulations (e.g., GDPR, PII)

Familiarity with clinical trial design and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)

Knowledge of industry-standard data analysis and reporting software (e.g., SAS and/or SQL)

Strong communication skills (written and verbal)

Strong customer service skills

Strong ability to fostering and promoting teamwork

Prior management and / or leadership experience

Ability to work independently, motivated to take initiative

Effective combination of people skills and assertiveness

Strong organizational skills

Ability to perform multiple project tasks

Experience facilitating customer interactions and understanding of customer pains / needs

Preferred

Masters preferred

Experience with IRT systems

Experience with eCOA systems (including handling data of validated instruments used for endpoints)

Understanding of various e-clinical technologies/software, specifically Interactive Response Technology products and eCOAs (electronic clinical outcomes assessments)

Knowledge of CDISC standards and data interchange formats (e.g., SDTM, ADaM)

Company

Almac Group

Glassdoor3.7

Almac Group is a contract development and manufacturing firm offering integrated services to pharmaceutical and biotech companies globally.

Founded in 2002

Craigavon, Craigavon, GBR

5001-10000 employees

https://www.almacgroup.com

H1B Sponsorship

Almac Group has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2024 (1)

2021 (1)