Manager II, External Clinical Data Management

Job Description

Job Schedule: HM needs a local candidate at least 1-2 days a week to meet with team and stakeholders.

The Manager, External Clinical Data Management (Level 2), is accountable for an end-to-end delivery of External data in Company R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers, etc.) Clinical Safety, CROs and External Vendors for the data services they provide to support drug development processes and global submissions. This position provides expertise within Data Management by partnering with internal and external stakeholders (e.g. Central Labs, Specialty Labs, Biomarker Vendors, Companion Diagnostics, etc.) to optimize data collection services on behalf of Company. This position also ensures quality delivery of all 3rd party data from diverse external providers for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. The position will perform validation of the electronically transmitted external data by ensuring all clinical & companion diagnostics data meet quality requirements and protocol defined analysis endpoints (primary, secondary, exploratory, etc.). This position also requires knowledge of external data concepts, working knowledge of data collections (EDC & Non-EDC), industry standards (CDISC / SDTM), and technical skills for integrating and importing external data received from CROs, Vendors and / or Partners. Performing oversight and execution of CDx development to facilitate science based CDx decision making would be preferrable. In addition, excellent verbal/written skills, analytical, organizational, and interpersonal skills for working effectively with people at different levels are some of the requirements of this role. Demonstrated ability to self-start, be solution-oriented, collaborate effectively with diverse stakeholders, and be accountable for results by working in a fast-paced environment.

Responsibilities - Leadership, Direction, and Strategy: Leads implementation of Program / Therapeutic level external data collection requirements by partnering will internal (BDM, Non-BDM Functions) and external stakeholders (Central Labs, Vendors, Specialty Labs, etc.) to drive consistency of data acquisition, processing, and reporting of diverse external data across DS Programs. Participates in Contract/SOW reviews and MSA discussions of External Vendors by engaging with key cross-functional stakeholders (Clinical Operations, Clinical Biomarkers, QCP, etc.) for establishing data collection, data standards and data cleaning needs for DS Programs / Studies. - Serve as the subject matter expert for Study Data Managers during the planning/start-up, conduct and close-out of external data management activities by managing Program / Therapeutic level external data collection process, study requirements as well as the overall process. Accountable for the maintenance, and peer review of key Company procedural documents (SOPs/SOIs), including external data templates, such as External File Transfer Specifications (EFTs), External Data Structure Specifications (eDTS) to ensure data standardization across programs. Acts as a primary point of contact for escalations related to quality of external data delivery. Identify quality issues pertaining to external data sets, data structures to ensure delivery is in line with agreed upon EFTs, eDTS, DS External Data Standards and Contract/SOW. Promotes Company values and quality workplace culture, collaboration in cross-functional and multicultural settings, and builds and maintains positive relationships with internal/external stakeholders/vendors/partners.

Skills:

- 4 or more years external data management background and strong knowledge of 3rd party vendor management and oversight of external data standards. Knowledge of CDISC and SDTM and industry standard data collection practices required

- 4 or more years Clinical data management experience in a medical device, pharmaceutical company, or similar environment (e.g., CRO); oncology, immunology or oncology or complex disease therapeutic area is a must. Working knowledge of Clinical trial data systems and/or EDC and related applications is a plus required

Education:

- Master's Degree in life sciences or related field (or equivalent experience) preferred

- Bachelor's Degree in life sciences or related field (or equivalent experience) required

- RN in life sciences or related field (or equivalent experience) preferredCompany Description

Hybrid remote