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Project Support Specialist

productfull-timeRemote, Serbia

SALARY

Not listed

WORK TYPE

remote

JOB TYPE

full-time

INDUSTRY

general

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About the role

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.&nbsp;

Due to continued growth we are currently seeking a Project Support Specialist.&nbsp;The Project Support Specialist will serve as a member of the project team providing cross-functional support with the goal of contributing toward efficient management of the studies to which they are assigned.

This position can be offered fully home based in the following locations - Poland, Serbia, Slovakia, Hungary or Romania.

Essential functions of the job include but are not limited to:&nbsp;

<ul>

<li>Creates and maintains the project timeline in MS Project or similar system. Ensures updates are captured and documented. Ensures the distribution of updates to study team members.</li>

<li>Schedules internal and external meetings, assists with preparing and circulating agendas, takes meeting minutes, circulates meeting minutes, and files meeting agendas and minutes in the Trial Master File.</li>

<li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Performs an array of activities in the Clinical Trial Management System (CTMS) including maintaining study milestone dates, updating study contact lists, maintaining enrolment projections as needed, and submitting helpdesk tickets and ensuring remediation is completed.</li>

<li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Prepares, assigns, and documents study-specific training in appropriate systems; manages and oversees the maintenance of training records. Identifies gaps in training and engages appropriate team members or escalates as needed.</li>

<li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Establishes a study-level Share Point site or similar shared working space and ensures appropriate access to study team, sponsors and others as appropriate.</li>

<li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Creates project-specific email boxes and maintains appropriate access to study team members.</li>

<li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Manages user access to study systems by submitting user requests to the Help Desk or similar, by reviewing team member access on a define periodic basis, and document access review.</li>

<li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Orders study supplies and addresses queries on study supplies.</li>

<li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Orders initial study binders. Collects, collates and prepares study binders and ensures shipping to the proper locations through printing vendor.</li>

<li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Maintains various study trackers as needed and directed by the Project Manager, Clinical Trial Manager or other project leader.</li>

<li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Sends communications to study sites, investigators and others, as directed by the Project Manager, Clinical Trial Manager or other Project Leadership, including SUSARs, email blasts, newsletters and other information that may be required.</li>

<li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">May support the distribution and tracking of IND Safety Reports/SUSARS/CIOMS according to the procedures defined by the study team in the project plan, as applicable, may be under Safety staff guidance.</li>

<li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">May support the translation process of site level documents, as applicable, per local and regional standards.</li>

<li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">May act as point of contact for project-related requests for team members, Sponsors, and third party vendors.</li>

<li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Supports the preparation, distribution, and the reconciliation of study material during applicable phases of the study (Operations Manual, ISF, patient cards, etc.) as applicable.</li>

<li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">May support team leaders with the production of various study reports and updates (e.g., country/site initiation, activation, recruitment).</li>

<li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Performs other duties as assigned by the Project Manager, Clinical Trial Manager or other Project Leadership.</li>

</ul>

Qualifications:

Minimum Required:

<ul>

<li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">4-year college degree, or equivalent experience ideally in a business, scientific or healthcare discipline</li>

<li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Minimum of 2 years of relevant experience as a Clinical Trial Assistant, Clinical Support Specialist or similar position.</li>

</ul>

Other Required:

<ul>

<li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Fluency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).</li>

<li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Customer service demeanour; demonstrate flexibility, teamwork, and a keen attention to detail.</li>

<li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Ability to communicate both verbally and in writing at the English proficiently (Professional level). Competencies:</li>

<li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Working knowledge of ICH-GCP, Precision SOPs, and regulatory guidance.</li>

<li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Demonstrates solid interpersonal skills.</li>

<li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment.</li>

<li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Strong written and verbal communication skills</li>

<li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Commitment to performing professionally consistent with Precision Principles.</li>

</ul>

#LI-OS1 #LI-Remote

<span class="ui-provider hf bzi bis bzj bzk bzl bzm bzn bzo bzp bzq bzr bzs bzt bzu bzv bzw bzx bzy bzz caa cab cac cae caf cag cah cai caj cak cal cam can cao cap" style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Precision medicine is revolutionizing the attack on cancer—and we are passionate about helping you harness its power. We strike tumours on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway.

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&nbsp;<div class="content-conclusion"><hr>

Any data provided as a part of this application will be stored in accordance with our&nbsp;<a href=" Policy.</a>&nbsp;For CA applicants, please also refer to our&nbsp;<a href=" Privacy Notice</a>.

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at <a href="mailto:"></a>.

Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at <a id="menur2oq" class="fui-Link ___1q1shib f2hkw1w f3rmtva f1ewtqcl fyind8e f1k6fduh f1w7gpdv fk6fouc fjoy568 figsok6 f1s184ao f1mk8lai fnbmjn9 f1o700av f13mvf36 f1cmlufx f9n3di6 f1ids18y f1tx3yz7 f1deo86v f1eh06m1 f1iescvh fhgqx19 f1olyrje f1p93eir f1nev41a f1h8hb77 f1lqvz6u f10aw75t fsle3fq f17ae5zn" href="mailto:" target="_blank"></a> so we can investigate and take appropriate action.</div>

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