Job Posting for Clinical Research Project Manager at Elligo Health Research
I. JOB SUMMARY The PM oversees the overall project tasks to ensure clinical trial deliverables are met and assumes responsibility of ensuring the smooth initiation of all clinical study operations under the direction of the department director.
II. SUPERVISORY RESPONSIBLITIES May delegate duties to project coordinators and/or navigators
III. RESPONSIBILITES
The PM works as a liaison between the different stakeholders within the trial to ensure communication flow stays intact
Develops and delegates specific guidance documents and tools, including communication flow charts, project workbooks and weekly overview metrics.
Ensures the study sites are receiving IRB approval, in some cases the PM would develop submission materials, and conduct quality assurance on all regulatory items specific to the trials being worked on
Analyzes site performance problems (protocol adherence) and identifies solutions; provides ongoing training for study sites as needed
Conducts remote review of data entered electronic Case Report Forms (eCRFs) for completion and correlation relating to site grant payments
Assess, reviews, and approves/rejects investigative sites for specific trials based off the trial requirement to conduct the study. Development of the minimum requirements and feasibility development may be needed as well
Management of specific trial recruitment needs for each of the trials you are PM on. This candidate will not place recruitment ads, but you will review them, ensure protocol accuracy, ensure within required budget, and ensure meeting the expectations of the sponsor for enrollment completion.
Reviews, approves, and rejects PM’d projects weekly/ monthly company timecards. This would fall in line with ensuring the specific project being managed stays within the expected hours allocated.
Involved in study specific budgets and change orders as needed. This includes site budgets, study overall budgets, new services budgets, change orders and amendments.
Accountability and coordination of study specific expenses
Communicate with the project coordinators to ensure site specific recruitment ads are meeting metrics for site enrollment expectations.
Manages internal department service line items that pertain the specific trial. i.e., recruitment, campaign management site starts up, regulatory, home health care, contracts & budgets, site payments under the oversight of the department director.
Works as a backup project manager on large global trials, as needed.
Ownership and/ or delegates taking study specific internal, external, client and vendor meeting agendas & minutes/ follow up action items.
Oversees and assists on booking, scheduling and overall organization of visits needed for trials opting into the home health care service line
Manages and oversees the Staffing projects under the direction of the department director. May also assist in identifying candidates for certain clinical trials that require us to staff specific technicians or coordinators for a study. This could also be for site specific staffing assistance as well and department staffing needs.
Manages and resolves conflicting priorities to deliver on commitments
Performs additional duties as assigned depending on department overall need
IV. KNOWLEDGE SKILLS AND ABILITIES REQUIRED
Minimum of 2-5 years of clinical research operations experience either on a private clinical research site level as a CRC or on a sponsor/CRO level as an in house CRA. (Candidates with only academic experience would not qualify for this position)
Available for full time position (Monday – Friday, 8 Hours Per Day)
Ability to work remotely during the pandemic but also available to work out of our Quincy, MA. facility permanently once normal office openings begin.
CCRP, CCRC or CCRA (or equivalent based off experience)
Proven ability to be careful, thorough, and detail-oriented
Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment
Ability to problem-solve unstructured or ambiguous challenges
Strong command of English, both written and verbal.
This position involves daily discussions with the sponsor, CRO and/or sites, the candidate must have excellent communication and interpersonal skills with customer service orientation to be qualified for this position
Working knowledge of Microsoft Office Outlook, Word, and Excel
Working knowledge of Google Drive, Docs, Spreadsheets and PowerPoint (Preferred)
Working knowledge of CTMS systems like Realtime or Clinical Conductor (Preferred)
Experience with Netsuite, salesforce and/or replicon (Preferred)
Self-starter who thrives in a collaborative, yet less structured team environment
V. WORKING CONDITIONS
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers.
Some flexibility in hours is allowed, but the employee must be available during the “core” work hours of 9:30 a.m. to 3:30 p.m. and must work 37.5 hours each week to maintain full-time status. Occasional evening and weekend work may be required as job duties demand.
The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel. More in-depth information can be found in SOP's, working guidelines, policies, etc.
Elligo is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Elligo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Elligo will not tolerate discrimination or harassment based on any of these characteristics. In addition, Elligo will provide reasonable accommodations for qualified individuals with disabilities.
Salary.com Estimation for Clinical Research Project Manager in Quincy, MA
$61,300 to $79,636
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