Your Future Beyond CDM

Certainly, experience in clinical data management (CDM) offers individuals many opportunities for career advancement within biopharmaceutical departments of data management and biometrics. But those same skills can also serve as a springboard to attractive careers in many other areas of drug development.

The technical expertise and attention to detail that clinical data associates and managers gain in designing case report forms, building databases, programming edit checks, conducting user acceptance testing, establishing medical dictionaries and coding conventions, writing data queries, and locking databases can also be leveraged as attractive qualifcations for jobs in clinical quality assurance, regulatory affairs, and clinical study management.

The interpersonal skills that clinical data associates and managers gain while serving on clinical study teams to critique clinical protocols and clinical study reports, harmonize clinical and safety databases, resolve data queries, support the activities of data monitoring committees and biostatisticians, and in general solve the multitude of problems that crop up during clinical studies, are the same skills needed to be successful as a clinical study manager, project manager, Clinical Quality Assurance (CQA) auditor, and regulatory affairs specialist.

Transitioning to Clinical Study Management

Clinical study managers have overall responsibility for planning, conducting, and completing clinical studies correctly and on time. In some companies, they also manage the studys budget. Whether clinical study managers have direct supervisory responsibilities or not, they must lead and harmonize the work of the clinical study team and are accountable for its progress.

CDM associates and data managers who previously worked as a site coordinator or clinical research associate have acquired technical skills (such as monitoring, implementing Good Clinical Practices (GCPs), and site management) that directly apply to managing a clinical study. However, even without clinical site experience, CDM skills such as understanding clinical protocols, solving database problems, interpreting laboratory test results, cataloging medical procedures, and coding adverse drug reactions are good experience for clinical study manager positions.

Clinical study managers must also have excellent organizational and leadership skills, coordinating the study teams activities as they plan, conduct, and close the study. Practice these skills within CDM by volunteering for special problem-solving assignments and gaining a reputation for meeting (or exceeding) target dates for completing CDM tasks—especially tasks that require coordination with CDM colleagues, subordinates, and vendors.

Transitioning to Project Management

Project managers are responsible for managing the interdisciplinary project team (usually consisting of not only clinical scientists but also representatives from preclinical development, chemistry, manufacturing, regulatory affairs, and marketing). Project managers work closely with the development programs team leader, who, during the clinical phases of development, is usually a physician. Development team leaders are responsible for both the scientifc and business aspects of the development program, overseeing all of the work required to develop a new drug. Project managers support the leader and other project team members by managing the project timelines, milestones, and resources and assisting with the development programs strategy.

The most important characteristic of successful project managers is communication skills. Often, they must manage people without direct authority and in?uence people who outrank them, using their well-developed skills to persuade, negotiate, and resolve problems. To become an attractive candidate for a project manager position, take advantage of every opportunity to hone your skills as a team player, fnding win-win solutions to problems, proactively providing status updates of your work progress, responding quickly to requests for information or assistance, making well-reasoned formal presentations, and writing clearly and concisely.

Project managers must also have a frm understanding of the drug development process, multinational regulatory requirements, the company』s business goals, and the inter- relationships between the clinical, preclinical, and manufacturing units. In addition to the GCPs that apply to data management, broaden your understanding of International Conference on Harmonization (ICH) guidelines for preclinical, manufacturing, and quality systems; learn about the scientifc aspects of the companys experimental drugs; and keep abreast of the company』s business strategy for new product development.

Transitioning to Clinical Quality Assurance

Another option is to transition from CDM to Clinical Quality Assurance (CQA) as a CQA auditor. CQA auditors inspect clinical study documents, clinical department processes, investigator sites and contractors, such as clinical research organizations, and ensure compliance with GCPs and the companys standard operating procedures (SOPs). Because of the heavy reliance on electronic systems for clinical data acquisition, CQA auditors also validate computer systems and audit procedures such as electronic signature security, biostatistics methods, and data acquisition equipment (e.g., portable cardiac monitors and electronic patient diaries). Experienced CQA auditors can advance to more responsible positions in CQA management such as quality assurance consulting, compliance training, and hosting inspections by regulatory authorities.

The same understanding of GCPs and attention to detail used to validate clinical databases, resolve queries, reconcile discrepancies, and clean clinical databases are skills used by CQA auditors. In addition, the interpersonal skills that CDM workers use in negotiating and solving problems with colleagues on clinical study teams are directly applicable to CQA auditors, who must encourage people to cooperate with an audit, even when the inspection uncovers defciencies requiring corrective action.

To qualify for a position in CQA, polish your skills in cleaning data, volunteer to write SOPs, master your understanding of regulatory standards, and practice how to interpret those standards in unusual clinical situations. In addition, develop diplomatic and constructive techniques for motivating co-workers to comply with regulatory requirements and SOPs.

Transitioning to Regulatory Affairs

Regulatory affairs specialists are responsible for managing the companys regulatory activities, compiling and submitting regulatory documents, communicating with regulatory authorities, and maintaining regulatory archives.

A separate operations group within regulatory affairs usually manages the companys electronic document management systems and compiles regulatory documents such as Investigational New Drug Applications (INDs) and Marketing Authorization Applications (MAAs). To compile, submit, and track documents during regulatory interactions, these regulatory workers must have a thorough understanding of validated document management systems and multi-national regulatory requirements. Others in regulatory affairs serve as consultants to the companys executives, development teams, and individual clinical study teams on regulatory matters, and as the liaison responsible for coordinating communications and transmitting information between the sponsoring company and regulatory authorities.

To become an attractive candidate for regulatory affairs positions, seek opportunities to become familiar with handling large blocks of information, such as merging databases for integrated summaries. In addition, seek opportunities to enhance your understanding of regulatory requirements and your oral and written communication skills.

How to Get Started – Make a Plan

Transitioning from CDM to another clinical research feld can be facilitated by taking a few simple steps. First, be flexible. Open positions often appear without warning, so be open-minded and consider each one as an opportunity, even if is not a "perfect ft." But also remember that successful candidates are prepared when opportunity knocks. And that requires some planning.

If a career change to project management, clinical study management, quality assurance, or regulatory affairs is attractive, start by polishing the skills that hiring managers view as essential for those positions. When given a choice of assignments within CDM, choose the one that will enhance your skills and experience to make you more attractive to the new hiring manager, like those suggestions listed above.

Next, take advantage of cross-functional activities by volunteering or agreeing to serve on working groups, special projects, company committees, etc. that involve scheduled, ongoing interactions with people in other clinical departments. Although you may be representing CDM and may be viewed as a CDM expert, these activities provide valuable insight about the goals, priorities, types of work, and the environment in other functional areas. These crossfunctional groups also provide a golden opportunity to become acquainted and network with key people in other departments; be a good team player, and your colleagues on these special projects may become valuable advocates to support hiring you.

Finally, consider joining a professional organization in your target area. The Drug Information Association offers specialty sections in clinical operations, project management, regulatory affairs, and quality systems. Other key organizations are the Project Management Institute, Regulatory Affairs Professional Society, and Association of Clinical Research Professionals. These organizations offer training courses, professional certifcation programs, newsletters, and other society publications; some also have local chapters and post job openings. Take advantage of these opportunities to improve your skills and network with professionals who can assist with your career transition.

In short, CDM associates and data managers have a wealth of choices in career paths. Certainly, advancement within CDM is rewarding, offering many opportunities for professional development. But CDM skills and experience are also attractive to hiring managers in other clinical research felds; managers who are always grateful to have a colleague with a sound technical understanding of clinical data systems, the ability to interact productively with people in cross-functional settings, and extensive experience in meeting deadlines with high-quality deliverables.

Rebecca J. Anderson has worked in the biopharmaceutical industry for more than 25 years, holding management positions in drug discovery, preclinical development, and project management at pharmaceutical, biotechnology, medical device, and contract research organizations. She has also served as the head of clinical business units. Rebecca holds a Ph.D. in pharmacology from Georgetown University. Prior to her career in industry, she held university faculty appointments and conducted basic research in pharmacology and toxicology. She currently works as a freelance writer and is the author of Career Opportunities in Clinical Drug Research www.cshlpress.com/link/ careerclinic.htm). She can be reached at rebeccanderson@msn. com.

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