Clinical Research Program Project Manager

Clinical Research Project Manager

The Neuroendocrine Unit is seeking a Clinical Research Project Manager to oversee assigned multidisciplinary clinical research studies in individuals with eating disorders with room for growth into a leadership role. The multidisciplinary NIH-funded research studies are overseen by Elizabeth A. Lawson, MD (Neuroendocrine Unit), Jennifer J. Thomas, PhD and Kamryn Eddy, PhD (Co-Directors, MGH Eating Disorders Clinical and Research Program).

The successful candidate is one who is ready to step into a long-term position with opportunities for career development and job growth as a key member of our highly collaborative clinical research team, consisting of multidisciplinary PIs, study clinicians (Nurse Practitioners and fellows), and clinical research coordinators. The Project Manager will oversee the daily operations of the assigned clinical research studies(s), helping to address complex scientific and regulatory issues, supervise research coordinator(s), direct/implement research protocols, manage data collection and integrity, and assist with grant and manuscript preparation. When a hurdle emerges, the Project Manager is expected to be deeply involved, lead the discussions for troubleshooting, and engage in and delegate the appropriate steps to getting it solved. S/he must show flexibility to help others when help is needed and possess the ability to quickly adapt to re-prioritizing his/her own work as needed to address critical issues that may arise.

The ideal candidate will possess strong written and verbal communication skills, have supervisory experience, and be well-versed in the operations of a clinical research program including compliance with Good Clinical Practices (GCP) and other regulations governing clinical research. This position will report directly to the lead Nurse Practitioner in the Neuroendocrine unit under the general supervision of the study PIs and will work closely and collaboratively with other team members in similar leadership roles (NPs and fellows) to ensure the consistent and efficient conduct of our clinical research. S/he will interact have direct report(s) that s/he will guide, support, and mentor.

Candidates must have experience with clinical research.

Interested candidates should submit a cover letter, three references, and a writing sample with his/her application.

RESPONSIBILITIES

* Collaborate with PIs on high-level planning activities concerned with technical and research developments.

* Strategize with PIs, research team members, and administrative staff when problems arise and offer solutions.

* Manage clinical research studies under the supervision of NP and PIs, including study start-up, active and close-out phases in compliance with GCP and applicable regulatory requirements.

* Able to independently anticipate potential challenges with study execution, critically evaluate issues and provide potential solutions

* Train and oversee clinical research coordinator(s) and day-to-day study activities to meet or exceed study completion goals, including providing guidance to direct report(s) on prioritizing their work and providing constructive feedback as needed.

* Draft and implement clinical trial protocols and amendments and other related study documentation to ensure compliance with MGH, IRB, NIH, and FDA regulatory requirements and research goals.

* Oversee study records management and data collection activities to ensure compliance and data integrity across studies. Maintain the schedules and procedures necessary for timely and complete data collection.

* Coordinate periodic and as-needed reports as required by regulations (e.g., IRB, DSMB, FDA, NIH), including independently authoring and editing documentation for review by others, and/or supervising others who may be generating these documents.

* Assist the PIs in drafting and preparing sections of manuscripts and grant applications, opportunities for authorship on conference presentations and publications.

* Develop and implement tracking systems as needed to ensure studies are executed per GCP compliance, and data monitoring and required regulatory reporting requirements are met. Ensure uniform application of regulatory requirements across studies in collaboration with fellows and NPs.

* Develop and implement procedures and policies to ensure consistency of implementation of best practices across clinical studies

* Schedule and manage meetings, lead discussions, summarize meeting notes and follow-up on action items.

* Recognize opportunities for staff cross training and cross coverage and create/implement plan to address the needs of the team.

EDUCATION AND QUALIFICATIONS

* Bachelor's degree and 3-5 years of related clinical research experience required including regulatory and data management experience

* Must have the ability to independently execute daily responsibilities with minimal supervision from manager

* Must have previous supervisory experience with direct report(s) and proficiency in managing personnel issues and ability to provide critical feedback to direct report(s)

* Computer skills including the use of the Microsoft Office suite, electronic data collection programs (e.g., RedCap), and data analysis software (e.g., R)

* Clinical Research Associate certification desirable

OTHER SKILLS AND KNOWLEDGE

* Able to make independent effective decisions, anticipate problems, and develop contingency plans

* Able to effectively supervise direct reports

* Able to maintain high productivity in time-sensitive situations and adapt to shifting priorities in response to changing deadlines and the needs of the program

* Flexibility and the ability to deal positively with organizational changes

* Excellent organizational skills

* Excellent written and verbal communication skills