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4 days old

Project Manager Lead / External Scientific Research Manager _ Gaithersburg, MD

Kelly Services
Gaithersburg, MD 20898
Kelly Services is currently seeking **Project Manager Lead / External Scientific Research Manager** for one of our top clients in Gaithersburg, MD.


Location is ONSITE in Gaithersburg preferably but will consider Onsite in Wilmington DE. Hiring Manager will NOT consider full remote workers.


Duration: 12 months


**Accountabilities/Responsibilities:**


+ Act as the primary local operational contact for local external organizations, ensuring that proposal guidelines and standards are met, escalating research proposals for review as appropriate

+ Support the review of External Scientific Research proposals to enable a consistent, high quality approach to evaluation

+ Ensure operational compliance with global and local policies, processes and procedures within a specific therapeutic area to ensure timely, cost efficient and high quality project delivery

+ Co-ordinate complex external research to ensure compliance with project management principles and internal process supporting external regulations to enable delivery of high quality research projects. This includes launch of new research trials.

+ Lead the project management of complex joint research projects ensuring compliance with project management guidelines, external regulations and internal processes to enable the delivery of high quality Investigator Initiated Sponsored Research and Externally Sponsored Collaborative Research (ESCR). This includes the initiation/maintenance of supplier contracts.

+ Revises all project planning in light of changing needs and requirements to ensure effective, efficient and compliant delivery of ESR.

+ Lead effective collaboration and communications between internal stakeholders and external partners to enable high quality research projects.

+ Manage projects to time, cost and quality, taking corrective action as required to ensure that project targets are met.

+ Contribute to ESRO metric/KPI reporting requirements to IMED, GMED, and TA leadership as required

+ Addresses as a matter of urgency any compliance issues, escalating problems as appropriate to the relevant ESRO member.

+ Supports the development of consistent project management processes across local ESR to enable a high quality project management approach

+ Ensure timely preparation of research CDAs/CSAs

+ Collaborate with Regulatory Affairs to ensure timely delivery of proper application/documents for submissions to Regulatory Authority

+ Prepare and maintain study budget in ESR web management system (ACCORD as necessary)

+ Ensure accurate payments related to the study are managed and comply with all local transparency requirements

+ Liaise with Local Compliance Officer regarding payments to Investigators to ensure these are in accordance with local requirements.

+ Maintain studies in ESR web management system, ensuring completeness of all essential documentation

+ Plan and lead activities associated with audits and regulatory inspections


**Minimum Requirements Education and Experience**


+ Bachelors degree within a scientific or healthcare field or significant and comparable experience

+ Project Management qualification or significant and comparable experience

+ Experience within the pharmaceutical industry ideally working within a clinical study/development field

+ Experience and knowledge of the clinical study and drug development processes and relevant guidelines, e.g., GCP/ICH for a specific therapeutic and geographical area

+ Other Skills and Capabilities

+ Effective relationship building and stakeholder management skills across functions, geographical boundaries and cultures

+ Creative and innovative approach to influence the development of more efficient and effective practices while operating with required policies and regulations

+ Flexibility and adaptability

+ High levels of enthusiasm and energy

+ High levels of organization


Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Email stalvnl@kellyservices.com for questions about the position but please apply online to be considered for the position.


Why Kelly?


+ As a Kelly Services employee, you will have access to numerous perks, including:

+ Exposure to a variety of career opportunities as a result of our expansive network of client companies

+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career

+ Access to more than 3,000 online training courses through our Kelly Learning Center

+ Weekly pay and service bonus plans

+ Group-rate insurance options available immediately upon hire*


Apply Today!


*Available for purchase and administered by a designated third-party vendor


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-10-11 Expires: 2021-11-11

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Project Manager Lead / External Scientific Research Manager _ Gaithersburg, MD

Kelly Services
Gaithersburg, MD 20898

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