Ref #: 27195

Employment type: Permanent - Full-Time

Location: US - MD (Remote)

Posted: 24-Feb-2021

Description

WHO WE ARE:

At DOCS, we care about our people and their passion, as they are the key to our success and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term career. We have over 4500 employees globally working on novel therapies that deliver real impact to patients in need.

All our team members have the independence to get the job done and support from the experienced leadership team when you need it. If you want a career with a difference, DOCS is the place for you.

PRIMARY RESPONSIBILITIES:


Company Sponsored Observational and Interventional Research:

• Support/coordinate protocol development and finalization
Manage Study Governance (post SDC)
• Support/coordinate all internal, study governance processes (e.g. MEORT, MARC, LSPC, Clinical Challenge)
External Service Provider Management
• Provide input into the selection of External Service Providers (ESPs), including Clinical Research Organizations (CROs)
• Support strategic handover meetings and kick off meetings
• Perform CRO oversight to help ensure project delivery within time, cost and quality
• Collaborate with CRO/ESP to ensure the study operational aspects are effectively undertaken and that they have clear remits for
delivery
• Manage study specific issues and escalations with ESPs/CROs.

Stakeholder Management

• Support Project team set-up and study sourcing activities
• Support effective collaboration with the scientific/medical counterpart, the Epidemiologist/Medical Affairs Leader (MAL) respectively,
as well as other internal cross functional global roles
• Report study updates for areas of responsibility from a time, cost and quality perspective to internal stakeholders (e.g. Evidence
Delivery Associate Director, EDAD)).
• Support implementation and upkeep of an effective communication approach, as well as roles and responsibilities between the
MEOR stakeholders and External Service Providers.
• Coordinate efforts/input of the external scientific community (e.g. (Inter)national Coordinating Investigators, Steering/Executive
Committee) during project design and delivery

Manage study finance:

• If leading a study, develop and maintain the overall study budget (internal and external study costs)
• Ensure transparency over areas of budget responsibility by updating through relevant systems (s.a. ACCORD) and platforms (PPC
meetings) and obtaining approval for budget changes
• Work with procurement on project agreement and manage subsequent out of scope changes for ESP/CRO
• Manage and reconcile Contracts, POs and invoices
• Support financial audit readiness and Sox attestation as needed

Other Project Management activities as applicable

• Support delivery of projects to agreed timelines (scorecard), within the approved budget and according to AstraZeneca quality
standards.
• Support global oversight over the operational study start up, implementation and closure and ensure inspection-readiness
• Support implementation of study-related change management within business strategy, s.a. assessment of scope changes.
• Ensure Compliance with Procedural Documents, Standards and Policies, international guidelines and local regulations at any time,
and report compliance breaches
• Undertake feasibility assessments with internal and external stakeholders
• Manage study systems reporting


DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.