C2C :: Clinical Program Manager - South Plainfield, New Jersey

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<p>Dear Partners/Job Seekers<br> <br> We have a <b>Corp to Corp</b> opening for 
<b>Clinical Program Manager in South Plainfield, New Jersey</b>, if you have 
matching candidates please submit their profiles <strong><a 
href="https://www.job4tech.com/jobs/2875519-clinical-program-manager-at-rang-technologies-inc?utm_source=JA04-Up&amp;utm_medium=Groups-email&amp;utm_campaign=Job-Alerts";>
 here</a></strong>. </p> <p>Candidates matching the requirements will be 
contacted. </p> <p><br></p>
<p></p> <table> <tr> <td> <p><strong>Title:</strong> </p> </td> <td> 
<p><strong>Clinical Program Manager</strong> </p> </td> </tr> <tr> <td> 
<p><strong>Location:</strong> </p> </td> <td> <p><strong>South Plainfield, 
NJ</strong> </p> </td> </tr> <tr> <td> <p><strong>Duration:</strong> </p> </td> 
<td> <p><strong>6+ Months Possible extension</strong> </p> </td> </tr> </table> 
<p>  </p> <p><strong>Job description:</strong> </p> <p>The Clinical Program 
Manager provides the scientific and operational expertise required to conduct 
clinical trials in accordance with appropriate regulatory requirements for one 
or more indications within or across therapeutic areas. This includes, but is 
not limited to: working as an integrated member of the clinical team to 
develop, implement, and manage clinical trial(s) from study design through 
close out; establishing/managing relationships with assigned investigator 
sites, vendors and consultants to ensure timelines and deliverables are met and 
that studies are conducted in accordance with appropriate regulatory 
requirements. The incumbent also reviews, and contributes to, if needed, the 
development of clinical study-related documents.   The incumbent works 
cross-functionally with internal departments and external resources on Clinical 
Research related issues.   The Clinical Program Manager supports adherence to 
relevant regulatory requirements and company Standard Operating Procedures 
{SOPs) as appropriate.    <strong>Primary duties/responsibilities: </strong>   
</p> <ul> <li>Participates in the research, writing and finalization of 
clinical study-related documents such as protocols, protocol amendments, study 
manuals, Informed Consent Forms {ICFs), Case Report Forms (CRFs), 
Investigator's Brochures {IBs), Clinical Study Reports {CSRs), regulatory 
submissions and other publications as required. </li> <li> Searches and reviews 
literature sources and summarizes and presents findings. </li> <li>Establishes 
and maintains relationships with assigned investigator sites, vendors and 
consultants. </li> <li> Prepares potential investigator site lists and assists 
with their evaluation for inclusion in the study; participates in negotiations 
and maintains investigator study budgets and assists with Clinical Trial 
Agreements as necessary; ensures essential clinical documents are in place for 
assigned sites to ensure timely site initiation and patient enrollment. </li> 
<li>Ensures investigator and investigator site personnel comply with protocols; 
recommends corrective action(s) as required. </li> <li> Assists in the 
oversight of the shipment of and return of clinical supplies (drug and 
non-drug) for assigned sites, as necessary </li> <li> Performs periodic review 
of clinical data to ensure the data is accurate and complete. </li> 
<li>Summarizes results from clinical studies for submission to global 
regulatory agencies. </li> <li> Maintains accurate and updated study files. 
</li> <li>Assists in the design and implementation of standardized work 
processes. </li> <li> Participates in the selection and oversight of external 
service providers, including CROs and other vendors as necessary. Contributes 
to, and participates in, budget development, contract negotiations and 
expenditure oversight </li> <li>Prepares investigator site lists for study 
feasibility and participates in their review and approval for inclusion in the 
study. Plans, coordinates and participates in investigator meetings including 
developing and presenting assigned sections of the meeting agenda/content. 
</li> <li> Recommends strategies for, and oversees, the execution of activities 
associated with clinical monitoring, safety, eligibility, enrollment, and data 
consistency. Assists in configuration and implementation of study-related 
systems as appropriate (i.e. data management, study drug tracking, etc.). </li> 
<li> Performs other tasks and assignments as needed and specified by 
management. </li> </ul> <p>  Requirements   Bachelor's degree in a scientific 
discipline and a minimum of 6 years of experience in clinical research working 
in a pharmaceutical, biotechnology, Contract Research Organization (CRO) or 
related environment.       </p> <p>Special knowledge or skills needed and/or 
licenses or certificates required. </p> <ul> <li>In-depth understanding of the 
drug development process. </li> <li> Working knowledge of, and experience with, 
clinical trial design, conduct, data acquisition and reporting. </li> 
<li>Working knowledge of Good Clinical Practice (GCP) and International 
Conference on Harmonization (ICH) guidelines. </li> <li> Proficiency with 
Microsoft Office. </li> <li>Excellent verbal and written communication and 
skills. </li> <li> Ability to work independently and collaboratively, as 
required, in a fast-paced, matrix team environment consisting of internal and 
external team members. </li> <li>Analytical thinker with excellent 
problem-solving skills and the ability to adapt to changing priorities and 
deadlines. </li> <li> Excellent planning, organization and time management 
skills including the ability to support and prioritize multiple projects. </li> 
</ul> <p>    </p> <p>*Special knowledge or skills and/or licenses or 
certificates preferred. </p> <p>    </p> <ul> <li>Prior involvement in 
investigational New Drug applications (INDs) and New Drug Applications (NDAs) 
submissions. </li> <li> Previous experience as a field monitor. </li> 
<li>Medical writing experience or training. </li> </ul> <ul><li>Experience with 
Microsoft Project. </li></ul> <br><br>   <a 
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