Ref #: 25721

Employment type: Permanent - Full-Time

Location: US - PA (Remote)

Posted: 12-Nov-2020

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.

JOB SUMMARY:

The GSM supports delivery of global clinical studies from study set-up through maintenance, close-out and study archiving. The GSM works cross-functionally with internal and external partners to lead & deliver aspects of the clinical study in accordance with Senior Global Study Leader (Sr. GSL) or Global Study Leader (GSL) delegation, applicable clinical trial regulations.

PRIMARY RESPONSIBILITIES:

• Perform study management tasks as per agreed delegation/oversight by Sr.
GSL/GSL.
• In partnership with internal experts and external service providers, provide
oversight (as delegated by the Sr. GSL/GSL) to ensure study delivery of both
internally-run and outsourced studies.
• Lead/contribute to the preparation of delegated study documents (e.g. Informed
Consent Form, applicable study plans, etc.), and external service provider-related
documents (e.g. specifications, study specific procedures, etc.)
• Maintain and facilitate interactions with both internal & external functions to
ensure efficient study delivery to time, costs and quality objectives.
• Manage the set-up and maintenance of third-party vendors.
• Support the Sr. GSL/GSL with budget management. Initiate contract/budget
requests for third-party vendors, facilitate generation of purchase orders, track
spend against approved budget and manage the change order process.
• Provide input to data management documents (e.g. Case Report Form, Data
Validation Specifications), and interface with data management representatives
and sites to facilitate the delivery of study data.
• Contribute to the planning and conduct of internal and external meetings.
• Ensure adequate supply of study materials by liaising with Clinical Supply Chain
or external service providers as appropriate.
• Proactively contribute to risk and issue identification, development of mitigation
and/or action plans for identified risks and issues.

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.

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